| 2026-08-10 |
P150031-S097 |
Vercise Deep Brain Stimulation (DBS) Systems |
30-Day Notice |
NHL |
— |
— |
| 2026-08-10 |
P030017-S398 |
Precision Spinal Cord Stimulator (SCS) Systems |
30-Day Notice |
LGW |
— |
— |
| 2026-08-07 |
P190006-S113 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
QON |
— |
— |
| 2026-08-07 |
P180046-S113 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
EZW |
— |
— |
| 2026-08-06 |
P180011-S069 |
Eluvia Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2026-08-06 |
P140028-S087 |
Innova Self Expanding Stent System |
30-Day Notice |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2026-08-06 |
P110035-S078 |
Epic Vascular Self-Expanding Stent System |
30-Day Notice |
NIO |
Stent, Iliac |
Unknown |
| 2026-08-04 |
P190019-S043 |
Ranger Paclitaxel-Coated Balloon Catheter |
Normal 180 Day Track |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2026-07-30 |
P230035-S009 |
AGENT Paclitaxel-Coated Balloon Catheter |
30-Day Notice |
OOB |
Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter |
Unknown |
| 2026-07-24 |
P190006-S110 |
Axonics Sacral Neuromodulation System |
Real-Time Process |
QON |
— |
— |
| 2026-07-24 |
P180046-S110 |
Axonics Sacral Neuromodulation System |
Real-Time Process |
EZW |
— |
— |
| 2026-07-23 |
P960040-S516 |
ICD INOGEN VR DF4 (D010); ICD INOGEN VR DF1/IS1 (D011); ICD INOGEN DR DF4/IS1 (D012); ICD INOGEN DR DF1/IS1 (D013); |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-07-23 |
P150012-S189 |
ESSENTIO MRI SR SL (L110); ESSENTIO MRI DR SL (L111); ESSENTIO MRI DR EL (L131); PROPONENT MRI SR SL (L210); PROPONE |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2026-07-23 |
P110042-S215 |
S-ICD EMBLEM GEN 2 (A209); S-ICD EMBLEM MRI (A219) |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-07-23 |
P010012-S613 |
MOMENTUM CRT-D IS1 DF4 IS1 (G124, G125); MOMENTUM CRT-D IS1 DF1 LV1 (G126); MOMENTUM X4 CRT-D IS1 DF1 IS4 (G128, G138 |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2026-07-23 |
N970003-S309 |
ESSENTIO SR SL (L100); ESSENTIO DR SL (L101); ESSENTIO DR EL (L121); PROPONENT SR SL (L200); PROPONENT DR SL (L201) |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2026-07-21 |
P130013-S086 |
WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Closure |
Real-Time Process |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2026-07-20 |
P200036-S011 |
eCoin Peripheral Neurostimulator |
30-Day Notice |
QPT |
Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence |
Unknown |
| 2026-07-16 |
P150031-S096 |
Vercise Deep Brain Stimulation (DBS) Systems |
30-Day Notice |
NHL |
— |
— |
| 2026-07-10 |
P150031-S095 |
Vercise Deep Brain Stimulation (DBS) Systems |
30-Day Notice |
NHL |
— |
— |
| 2026-07-10 |
P030017-S397 |
Precision Spinal Cord Stimulator (SCS) Systems |
30-Day Notice |
LGW |
— |
— |
| 2026-07-07 |
P110042-S210 |
EMBLEM S-ICD Electrode (Lead) Model 3501 |
Normal 180 Day Track No User Fee |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-07-01 |
P960040-S513 |
TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-07-01 |
P910077-S198 |
LATITUDE NXT Remote Patient Management System; LATITUDE NXT System Server Software Model 6460 |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-07-01 |
P170023-S024 |
Bulkamid Urethral Bulking System |
30-Day Notice |
LNM |
Agent, Bulking, Injectable For Gastro-Urology Use |
Unknown |
| 2026-07-01 |
P150012-S182 |
INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2026-07-01 |
P110042-S214 |
Emblem S-ICD (A209); Emblem MRI S-ICD (A219) |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-07-01 |
P110042-S211 |
EMBLEM S-ICD |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-07-01 |
P010012-S607 |
COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT |
Real-Time Process |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2026-07-01 |
N970003-S307 |
ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA and ALTRUA 2 |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2026-06-17 |
P190006-S112 |
Axonics SNM System |
30-Day Notice |
QON |
— |
— |
| 2026-06-17 |
P180046-S112 |
Axonics SNM System |
30-Day Notice |
EZW |
— |
— |
| 2026-06-09 |
P910073-S192 |
RELIANCE S Passive Single Coil, RELIANCE S Active Fix Single Coil, RELIANCE Passive Dual Coil, RELIANCE Active Fix Dual |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-06-09 |
P150012-S188 |
LD INGEVITY PLUS AF |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2026-06-09 |
P010012-S611 |
ACUITY SPIRAL, ACUITY X4 Straight, ACUITY X4 Spiral S, ACUITY X4 Spiral L |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2026-06-04 |
P200029-S013 |
TheraSphere Y-90 Glass Microspheres System |
30-Day Notice |
NAW |
Microspheres Radionuclide |
Unknown |
| 2026-06-03 |
P960040-S514 |
INOGEN, DYNAGEN, MOMENTUM, VIGILANT EL, PERCIVA MINI, RESONATE EL, PERCIVA HF, RESONATE HF |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-06-03 |
P960004-S116 |
ThinLine/FineLine Family of Endocardial Pacing Leads Models: 4456, 4457, 4469, 4470, 4471, 4479, 4480 |
30-Day Notice |
NVN |
— |
— |
| 2026-06-03 |
P910073-S191 |
Endotak Reliance Leads (0128, 0137, 0138, 0147, 0148, 0157, 0158); Endotak Reliance 4-Site Leads (0262, 0263, 0265, 0266 |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-06-03 |
P150012-S186 |
Ingevity MRI Leads: Ingevity MRI Lead Models: 7731, 7732, 7735, 7736, 7740, 7741, 7742 Ingevity+ Lead Models: 7831, 7832 |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2026-06-03 |
P150012-S185 |
ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2026-06-03 |
P110042-S213 |
S-ICD Electrode Model: 3501 |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-06-03 |
P110042-S212 |
EMBLEM, EMBLEM MRI |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-06-03 |
P010012-S610 |
EasyTrak, Acuity Spiral and Acuity x4 Leads: ACuity Spiral Lead Model: 4592 Acuity x4 Lead Models: 4671, 4672, 4674, 467 |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2026-06-03 |
P010012-S609 |
MOMENTUM, MOMENTUM X4, INOGEN, DYNAGEN, VIGILANT, VIGILANT X4, RESONATE, RESONATE X4, RESONATE HF |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2026-06-03 |
N970003-S308 |
ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2026-06-01 |
P150012-S187 |
INGEVITYTM+ Lead Passive Models |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2026-05-29 |
P220032-S012 |
POLARx and POLARx Cryoablation Balloon Catheters; POLARSHEATH Steerable Sheaths; SMARTFREEZE Cryoablation System Console |
Normal 180 Day Track No User Fee |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2026-05-29 |
P190006-S111 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2026-05-29 |
P180046-S111 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2026-05-28 |
P150031-S092 |
Deep Brain Stimulation (DBS) Systems |
Real-Time Process |
NHL |
— |
— |
| 2026-05-28 |
P030017-S393 |
Spinal Cord Stimulation (SCS) |
Real-Time Process |
LGW |
— |
— |
| 2026-05-21 |
P030017-S392 |
Celestia Implantable Pulse Generator, Celestia External Trial Stimulator |
Real-Time Process |
LGW |
— |
— |
| 2026-05-19 |
P150012-S184 |
INGEVITY MRI; INGEVITY+; INGEVITY+ Passive |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2026-05-18 |
P150031-S094 |
Vercise Deep Brain Stimulation (DBS) Systems |
30-Day Notice |
NHL |
— |
— |
| 2026-05-18 |
P130013-S084 |
WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Closure |
Real-Time Process |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2026-05-18 |
P030017-S395 |
Precision Spinal Cord Stimulator (SCS) Systems |
30-Day Notice |
LGW |
— |
— |
| 2026-05-18 |
N970012-S211 |
AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone |
Real-Time Process |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2026-05-15 |
P960006-S059 |
Fixation Tool (Model 6616) |
30-Day Notice |
NVN |
— |
— |
| 2026-05-15 |
P960004-S115 |
Stylet (Models 6033, 6034, 6036, 6037, 6039, 6040, 6042, 6043, 6053, 6054, 6055, 6058, 6059, 6062, 6063, 6064, 6065, 606 |
30-Day Notice |
NVN |
— |
— |
| 2026-05-15 |
P930035-S037 |
Hex Wrench (#2) (Model 6501) |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-05-15 |
P910077-S199 |
DF-1 Plug (Model 6996) |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-05-15 |
P910073-S190 |
ACUITY X4 Connector Tool (Model 4625); RELIANCE 4-FRONT Suture Sleeve (aka Lead Stabilizer) (Model 6403); Lead Cap Kit |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-05-15 |
P830060-S093 |
Vein Pick (Model 6541) |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-05-15 |
P150012-S183 |
Stylet Models (5003, 5004, 5005, 5012, 5013, 5014); INGEVITY Attachable Suture Sleeve (aka Lead Stabilizer) (Model 6402 |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2026-05-15 |
P010012-S608 |
ACUITY X4 Suture Sleeve (aka Lead Stabilizer) (Model 4603); ACUITY X4 Flushing Tool/Wire Guide (Model 4604) |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2026-05-13 |
P150031-S093 |
(Vercise Deep Brain Stimulation (DBS) Systems) |
30-Day Notice |
NHL |
— |
— |
| 2026-05-13 |
P030017-S394 |
Precision Spinal Cord Stimulator (SCS) Systems |
30-Day Notice |
LGW |
— |
— |
| 2026-05-06 |
P980033-S067 |
WALLSTENT Venous Endoprosthesis with Unistep Plus Delivery System |
30-Day Notice |
QKJ |
Stent, Central Venous |
Unknown |
| 2026-05-06 |
P900056-S225 |
ROTABLATOR Rotational Atherectomy System |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2026-05-06 |
P140028-S085 |
Innova Vascular Self-Expanding Stent System |
30-Day Notice |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2026-05-06 |
P110035-S076 |
Epic Vascular Self-Expanding Stent System |
30-Day Notice |
NIO |
Stent, Iliac |
Unknown |
| 2026-05-06 |
P090003-S057 |
Express LD ILIAC Premounted Stent System |
30-Day Notice |
NIO |
Stent, Iliac |
Unknown |
| 2026-05-01 |
P190019-S040 |
Ranger Paclitaxel-Coated PTA Balloon Catheter |
135 Review Track For 30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2026-04-24 |
P190019-S042 |
RANGER Paclitaxel-Coated PTA Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2026-04-23 |
P130013-S085 |
WATCHMAN FLXTM Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLXTM Pro Left Atrial Appendage Closu |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2026-04-22 |
P910073-S189 |
RELIANCE S Active Fix Single Coil IS-1/DF-1 59cm (Model 0137); RELIANCE S Active Fix Single Coil IS-1/DF-1 64cm (Model 0 |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-04-22 |
P010012-S606 |
ACUITY Spiral (Model 4592); ACUITY X4 Straight (Model 4593); ACUITY X4 Straight (Model 4672); ACUITY X4 Spiral S (Model |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2026-04-21 |
P960040-S507 |
Implantable Cardioverter Defibrillators (ICD) RESONATE: D420, D421, D432, D433, D520, D521, D532, D533; MOMENTUM: D120, |
Normal 180 Day Track |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-04-21 |
P010012-S594 |
Cardiac Resynchronization Therapy Defibrillators (CRT-D) RESONATE: G524, G525, G526, G528, G537, G547, G548, G424, G425, |
Normal 180 Day Track |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2026-04-10 |
P960006-S058 |
Fixation Tool Model 6616 |
Real-Time Process |
NVN |
— |
— |
| 2026-04-10 |
P960004-S114 |
Straight Lead Stylets Limber Models 6033, 6034; Straight Lead Stylets Firm Models 6036, 6037; J Shaped Lead Stylets Limb |
Real-Time Process |
NVN |
— |
— |
| 2026-04-10 |
P930035-S036 |
Wrench Kit Model 6501 |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-04-10 |
P910077-S197 |
Lead Port Plug Model 6996 |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-04-10 |
P910073-S188 |
ACUITY X4 Connector Tool Model 4625 AICD Lead Stylets Firm Model 6971 AICD Lead Stylets Soft Model 6972 Suture S |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-04-10 |
P830060-S092 |
Vein Pick Model 6541 |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-04-10 |
P200029-S012 |
TheraSphere |
Normal 180 Day Track No User Fee |
NAW |
Microspheres Radionuclide |
Unknown |
| 2026-04-10 |
P150012-S181 |
Lead Stylets, Straight, X-Soft Models 5003, 5004, 5005 Lead Stylets, Long Tapered, Soft Models 5012, 5013, 5014 |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2026-04-10 |
P010012-S604 |
Suture Sleeve Model 4603, 6402 , ACUITY X4 Flushing tool/Wire guide Model 4604, Lead Cap Model 6742, Torque Wrench, Mode |
Real-Time Process |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2026-04-09 |
P900056-S224 |
Rotablator; ROTAPRO Rotational Atherectomy Systems |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2026-04-07 |
P190006-S109 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2026-04-07 |
P180046-S109 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2026-04-02 |
P110035-S075 |
EPIC Self-Expanding Stent System |
30-Day Notice |
NIO |
Stent, Iliac |
Unknown |
| 2026-04-01 |
P960040-S512 |
VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-04-01 |
P010012-S605 |
CONTAK CD, EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILL |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2026-04-01 |
N970003-S306 |
PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2026-03-27 |
P190006-S100 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
QON |
— |
— |
| 2026-03-27 |
P180046-S100 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
EZW |
— |
— |
| 2026-03-25 |
P130013-S076 |
WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY |
Normal 180 Day Track No User Fee |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2026-03-18 |
P150012-S178 |
INGEVITY+ Pace / Sense Lead Tined Fixation Models 7831 (52 cm, Straight) 7832 (59 cm, Straight) 7835 (45 cm, Atrial J |
Normal 180 Day Track |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2026-03-12 |
P190019-S041 |
Ranger Paclitaxel-Coated PTA Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2026-03-10 |
P130030 |
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE |
Original |
MAF |
Stent, Coronary |
Unknown |
| 2026-03-09 |
P190006-S099 |
Axonics Sacral Neuromodulation System |
135 Review Track For 30-Day Notice |
QON |
— |
— |
| 2026-03-09 |
P180046-S099 |
Axonics Sacral Neuromodulation System |
135 Review Track For 30-Day Notice |
EZW |
— |
— |
| 2026-03-06 |
P910073-S187 |
ENDOTAK RELIANCE / RELIANCE 4-FRONT pace/sense defibrillation leads |
Normal 180 Day Track No User Fee |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-03-05 |
P900056-S223 |
ROTAPRO Rotational Atherectomy System |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2026-03-03 |
P200036-S010 |
eCoin Peripheral Neurostimulator |
Normal 180 Day Track No User Fee |
QPT |
Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence |
Unknown |
| 2026-02-27 |
P190006-S107 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2026-02-27 |
P190006-S105 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2026-02-27 |
P180046-S107 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2026-02-27 |
P180046-S105 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2026-02-25 |
P190006-S108 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2026-02-25 |
P180046-S108 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2026-02-25 |
P000053-S141 |
AMS 800 Artificial Urinary Sphincter (AUS) |
30-Day Notice |
EZY |
Device, Incontinence, Mechanical/Hydraulic |
Gastroenterology, Urology |
| 2026-02-24 |
P190006-S106 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2026-02-24 |
P180046-S106 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2026-02-20 |
P910073-S185 |
ENDOTAK RELIANCE / RELIANCE 4-FRONT pace/sense defibrillation leads |
Normal 180 Day Track No User Fee |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-02-20 |
P110042-S203 |
EMBLEM S-ICD Electrode (Lead) |
Normal 180 Day Track |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-02-13 |
P910073-S186 |
RELIANCE 4-FRONT/model 0636; RELIANCE 4-FRONT/ model 0662; RELIANCE 4-FRONT/ model 0663 00802526592805 P910073; RELIANC |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-02-13 |
P150012-S179 |
INGEVITY MRI/ model 7731; INGEVITY MRI/ model 7732; INGEVITY MRI/ model 7735; INGEVITY MRI/ model 7736; INGEVITY MR |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2026-02-13 |
P110042-S208 |
EMBLEM S-ICD/ model 3501 |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-02-13 |
P010012-S602 |
ACUITY X4 Straight/ model 4671; ACUITY X4 Straight/ model 4672; ACUITY X4 Spiral S/ model 4674; ACUITY X4 Spiral S/ mod |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2026-02-12 |
P130013-S083 |
WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2026-02-11 |
P230035-S006 |
AGENT Paclitaxel-Coated Balloon Catheter |
Normal 180 Day Track No User Fee |
OOB |
Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter |
Unknown |
| 2026-02-11 |
P030017-S387 |
Precision Spinal Cord Stimulator (SCS) Systems Introducer Hub Mold Change |
135 Review Track For 30-Day Notice |
LGW |
— |
— |
| 2026-02-10 |
P200029-S011 |
TheraSphere |
Panel Track |
NAW |
Microspheres Radionuclide |
Unknown |
| 2026-01-30 |
P180011-S060 |
Eluvia Drug-Eluting Vascular Stent System |
Normal 180 Day Track No User Fee |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2026-01-27 |
P950020-S148 |
WOLVERINE Coronary Cutting Balloon |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2026-01-22 |
P150031-S091 |
Vercise Deep Brain Stimulation (DBS) Systems |
30-Day Notice |
NHL |
— |
— |
| 2026-01-22 |
P030017-S391 |
Precision Spinal Cord Stimulator (SCS) Systems |
30-Day Notice |
LGW |
— |
— |
| 2026-01-21 |
P030017-S377 |
Precision Spinal Cord Stimulator (SCS) Systems |
Normal 180 Day Track |
LGW |
— |
— |
| 2026-01-14 |
P190006-S104 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2026-01-14 |
P180046-S104 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2026-01-13 |
P190006-S103 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2026-01-13 |
P180046-S103 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2026-01-09 |
P150012-S177 |
INGEVITY Family Bradycardia Leads |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2026-01-08 |
P960040-S505 |
NG3 Implantable Cardioverter Defibrillators (ICDs): DYNAGEN Models: D020, D021, D022, D023, D150, D151, D152, D153; INOG |
135 Review Track For 30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-01-08 |
P150012-S169 |
Accolade MRI Pacemakers- ACCOLADE MRI Models: L310, L311, L331; ESSENTIO MRI Models: L110, L111, L131; PROPONENT Models: |
135 Review Track For 30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2026-01-08 |
P140026-S033 |
ENROUTE Transcarotid Stent System |
30-Day Notice |
NIM |
— |
— |
| 2026-01-08 |
P110042-S204 |
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD): EMBLEM S-ICD Model A209 and EMBLEM MRI S-ICD Model A219 |
135 Review Track For 30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-01-08 |
P010012-S592 |
NG3 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds): DYNAGEN Models: G150, G151, G154, G156, G158; INOGEN Mode |
135 Review Track For 30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2026-01-08 |
N970003-S301 |
Accolade Pacemakers: ACCOLADE Models: L300, L301, L321; ALTRUA 2 Models: S701, S702, S722; ESSENTIO Models: L100, L101, |
135 Review Track For 30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2026-01-07 |
P190006-S102 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2026-01-07 |
P180046-S102 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2026-01-05 |
P140008-S028 |
ORBERA INTRAGASTRIC BALLOON |
Normal 180 Day Track No User Fee |
LTI |
Implant, Intragastric For Morbid Obesity |
Unknown |
| 2026-01-02 |
P170023-S023 |
Bulkamid Urethral Bulking System |
30-Day Notice |
LNM |
Agent, Bulking, Injectable For Gastro-Urology Use |
Unknown |
| 2025-12-19 |
P190006-S101 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2025-12-19 |
P180046-S101 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2025-12-19 |
P150012-S173 |
ESSENTIO MRI (Models L110, L111, L131) PROPONENT MRI (Models L210, L211, L231) ACCOLADE MRI (Models L310, L311, L331) |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-12-19 |
N970003-S304 |
ALTRUA 2 (Models S701, S702, S722) ESSENTIO (Models L100, L101, L121) PROPONENT (Models L200, L201, L221) ACCOLADE ( |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-12-18 |
P130013-S082 |
WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Cl |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2025-12-18 |
P030017-S374 |
WaveWriter Alpha Spinal Cord Stimulator (SCS) Mixed Systems, M8 Adaptor |
Real-Time Process |
LGW |
— |
— |
| 2025-12-17 |
P150031-S090 |
Vercise Deep Brain Stimulation (DBS) Systems |
30-Day Notice |
NHL |
— |
— |
| 2025-12-17 |
P150012-S175 |
ESSENTIO MRI (Model L131); PROPONENT MRI (Model L231); ACCOLADE MRI (Model L331) |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-12-17 |
P030017-S390 |
Precision Spinal Cord Stimulator (SCS) Systems |
30-Day Notice |
LGW |
— |
— |
| 2025-12-17 |
N970003-S305 |
ALTRUA 2 (Model S722); ESSENTIO (Model L121); PROPONENT (Model L221); ACCOLADE (Model L321) |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-12-15 |
P130013-S079 |
WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System |
Normal 180 Day Track No User Fee |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2025-12-15 |
P130013-S078 |
WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System |
Normal 180 Day Track No User Fee |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2025-12-12 |
P130013-S080 |
WATCHMAN FLX Left Atrial Appendage (LAA) Closure Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage ( |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2025-12-10 |
P150031-S089 |
Vercise Genus Deep Brain Stimulation (DBS) Systems |
Real-Time Process |
NHL |
— |
— |
| 2025-12-10 |
P030017-S389 |
WaveWriter Alpha Prime Spinal Cord Stimulation (SCS) Systems |
Real-Time Process |
LGW |
— |
— |
| 2025-12-05 |
P150005-S090 |
Intellagen Irrigation Tubing Set |
Normal 180 Day Track |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2025-12-01 |
P950020-S147 |
WOLVERINE Coronary Cutting Balloon |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2025-11-06 |
P130013-S081 |
WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Left Atrial Appendage Closure D |
Special (Immediate Track) |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2025-10-29 |
P150003-S110 |
SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2025-10-27 |
P900056-S222 |
ROTAPRO Rotational Atherectomy System |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2025-10-24 |
P960004-S109 |
FINELINE II Leads |
Real-Time Process |
NVN |
— |
— |
| 2025-10-24 |
P910073-S182 |
ENDOTAK RELIANCE Leads |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-10-24 |
P230035-S007 |
AGENT Paclitaxel-Coated Balloon Catheter |
30-Day Notice |
OOB |
Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter |
Unknown |
| 2025-10-24 |
P190019-S039 |
Ranger Paclitaxel-Coated PTA Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2025-10-24 |
P180011-S067 |
Eluvia Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2025-10-24 |
P140028-S084 |
Innova Vascular Self-Expanding Stent System |
30-Day Notice |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2025-10-24 |
P010012-S593 |
ACUITY X4 Leads |
Real-Time Process |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2025-10-23 |
P140026-S032 |
ENROUTE® Transcarotid Stent System |
30-Day Notice |
NIM |
— |
— |
| 2025-10-22 |
P960040-S511 |
D010 INOGEN MINI ICD VR,D011 INOGEN MINI ICD VR,D012 INOGEN MINI ICD DR,D013 INOGEN MINI ICD DR,D020 DYNAGEN MINI I |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-10-22 |
P960040-S510 |
D010 INOGEN MINI ICD VR, D011 INOGEN MINI ICD VR, D012 INOGEN MINI ICD DR, D013 INOGEN MINI ICD DR, D020 DYNAGEN MI |
30-Day Notice |
— |
— |
— |
| 2025-10-22 |
P150012-S172 |
L110 ESSENTIO MRI SR,L111 ESSENTIO MRI DR,L131 ESSENTIO MRI EL DR,L210 PROPONENT,L211 PROPONENT,L231 PROPONENT,L310 A |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-10-22 |
P110042-S206 |
A209 SICD Gen 2,A219 SICD MRI |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-10-22 |
P010012-S599 |
G124 MOMENTUM CRT-D,G125 MOMENTUM CRT-D,G126 MOMENTUM CRT-D,G128 MOMENTUM,G138 MOMENTUM X4 CRT-D,G140 INOGEN CRT-D, |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2025-10-22 |
P010012-S598 |
G124 MOMENTUM CRT-D, G125 MOMENTUM CRT-D, G126 MOMENTUM CRT-D, G128 MOMENTUM, G138 MOMENTUM X4 CRT-D, G140 INOGEN C |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2025-10-22 |
N970003-S303 |
L100 ESSENTIO SR,L101 ESSENTIO DR,L121 ESSENTIO EL DR,L200 PROPONENT SR,L201 PROPONENT DR,L221 PROPONENT EL DR,L30 |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-10-17 |
P920047-S138 |
RHYTHMIA HDx Ablation Connection Box (for INTELLAGEN) (M004RA65010) |
30-Day Notice |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2025-10-17 |
P150005-S091 |
RHYTHMIA HDx Ablation Connection Box (for INTELLAGEN) (M004RA65010); Rhythmia HDx Ablation Connection Box (Maestro) |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2025-10-17 |
P020025-S147 |
RHYTHMIA HDx Ablation Connection Box (for INTELLAGEN) (M004RA65010); Rhythmia HDx Ablation Connection Box (Maestro) |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2025-10-02 |
P200036-S009 |
eCoin Tibial Nerve Stimulator System |
30-Day Notice |
QPT |
Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence |
Unknown |
| 2025-10-02 |
N970012-S210 |
AMS 700 Inflatable Penile Prosthesis with and without InhibiZone |
30-Day Notice |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2025-09-22 |
P960040-S508 |
Implantable Cardioverter Defibrillator, INOGEN (Models D010, D011, D012, D013, D140, D141, D142, D143); DYNAGEN (Models |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-09-22 |
P150012-S170 |
Accolade MRI Pacemakers, ESSENTIO MRI (Models L110, L111, L131); PROPONENT MRI (Models L210, L211, L231); ACCOLADE MRI ( |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-09-22 |
P010012-S595 |
Cardiac Resynchronization Therapy Defibrillators INOGEN (Models G140, G141, G146, G148); DYNAGEN (Models G150, G151, G15 |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2025-09-22 |
N970003-S302 |
Accolade Non-MRI Pacemakers ALTRUA 2 (Models S701, S702, S722); ESSENTIO (Models L100, L101, L121); PROPONENT (Models |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-09-19 |
P150031-S087 |
Vercise Deep Brain Stimulation (DBS) Systems |
30-Day Notice |
NHL |
— |
— |
| 2025-09-19 |
P050019-S043 |
Carotid Wallstent Monorail Endoprosthesis |
Special (Immediate Track) |
NIM |
— |
— |
| 2025-09-19 |
P030017-S386 |
Precision Spinal Cord Stimulator (SCS) Systems |
30-Day Notice |
LGW |
— |
— |
| 2025-09-16 |
P960040-S509 |
VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-09-16 |
P960006-S057 |
ACC SUP FIXATION TOOL |
30-Day Notice |
NVN |
— |
— |
| 2025-09-16 |
P960004-S110 |
ACC STY ITM STR .016 52CM; ACC STY ITM STR .016 45CM; ACC STY ITM STR .014 58CM; ACC STY ITM STR .014 52CM; ACC STY ITM |
30-Day Notice |
NVN |
— |
— |
| 2025-09-16 |
P930035-S035 |
ACC WRENCH |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-09-16 |
P910077-S196 |
ACC SUP PLUG |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-09-16 |
P910073-S183 |
ACC SUP CONNECTOR QUAD PSA TO IS4; ACC SUP SUTURE SLEEVE; ACC SUP KIT LD CAP; STRL PKG LEAD REPAIR KIT; ACC STY STR .016 |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-09-16 |
P830060-S091 |
ACC SUP VEIN PICK |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-09-16 |
P150012-S171 |
ACC STY TPR 0.013 - Accessory Stylet Straight, X-Soft; ACC STY 0.014 SOFT LONG TPR - Accessory Stylet Long Taper, Soft; |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-09-16 |
P110042-S205 |
SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-09-16 |
P010012-S597 |
ACC SUP SUTURE SLEEVE; ACC SUP FLUSHING TOOL; ACC WRENCH TORQUE-BI; ACC SUP LD CAP LV1 |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2025-09-16 |
P010012-S596 |
CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2025-09-04 |
P130013-S077 |
WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY |
Real-Time Process |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2025-09-03 |
P010012-S591 |
ACUITY X4 Straight, Models 4671 and 4672; ACUITY X4 Spiral S, Models 4674 and 4675; ACUITY X4 Spiral L, Models 4677 and |
Real-Time Process |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2025-09-02 |
P150005-S088 |
Opal HDx Ablation Connection Box (Maestro); Opal HDx Ablation Connection Box - IntellaNav StablePoint; Opal HDx Ablation |
Normal 180 Day Track No User Fee |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2025-08-22 |
P960004-S106 |
FINELINE® II EZ Sterox |
135 Review Track For 30-Day Notice |
NVN |
— |
— |
| 2025-08-22 |
P910073-S176 |
ENDOTAK RELIANCE® S, ENDOTAK RELIANCE®, ENDOTAK RELIANCE® SG, ENDOTAK RELIANCE® G, RELIANCE 4-FRONT |
135 Review Track For 30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-08-22 |
P150012-S153 |
INGEVITY MRI, INGEVITY + |
135 Review Track For 30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-08-19 |
P960004-S108 |
THINLINE ENDOCARDIAL PACING LEADS |
30-Day Notice |
NVN |
— |
— |
| 2025-08-14 |
P920047-S137 |
Blazer II Cardiac Ablation System and Cable |
Normal 180 Day Track No User Fee |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2025-08-14 |
P900056-S221 |
ROTABLATOR Rotational Atherectomy System |
Normal 180 Day Track No User Fee |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2025-08-14 |
P220032-S011 |
POLARx Cryoablation System |
Normal 180 Day Track No User Fee |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2025-08-14 |
P150005-S089 |
Blazer Open-Irrigated Ablation Catheter |
Normal 180 Day Track No User Fee |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2025-08-14 |
P020025-S146 |
Blazer II XP Cardiac Ablation Catheter and Cable |
Normal 180 Day Track No User Fee |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2025-08-08 |
P180011-S066 |
Eluvia Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2025-08-08 |
P140028-S083 |
lnnova Vascular Self Expanding Stent |
30-Day Notice |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2025-08-08 |
P110035-S074 |
Epic Vascular Self-Expanding Stent System |
30-Day Notice |
NIO |
Stent, Iliac |
Unknown |
| 2025-08-01 |
P980037-S095 |
AngioJet Thrombectomy System |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2025-07-28 |
P960004-S107 |
Stylets Models 6053, 6054, 6055 |
Normal 180 Day Track No User Fee |
NVN |
— |
— |
| 2025-07-16 |
P200036-S008 |
eCoin Peripheral Neurostimulator |
Normal 180 Day Track No User Fee |
QPT |
Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence |
Unknown |
| 2025-07-16 |
P130013-S074 |
WATCHMAN FLX Left Atrial Appendage (LAA) Closure Technology, WATCHMAN FLX Left Atrial Appendage Closure Device with Deli |
Panel Track |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2025-07-14 |
P000053-S140 |
AMS 800 Artificial Urinary Sphincter (AUS) |
30-Day Notice |
EZY |
Device, Incontinence, Mechanical/Hydraulic |
Gastroenterology, Urology |
| 2025-07-14 |
N970012-S209 |
AMS 700 Inflatable Penile Prosthesis (IPP) |
30-Day Notice |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2025-07-11 |
P150012-S168 |
ESSENTIO MRI (Models L110, L111, L131); PROPONENT MRI (Models L210, L211, L231); ACCOLADE MRI (Models L310, L311, L33 |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-07-11 |
P140008-S027 |
Orbera® Intragastric Balloon (IGB) System |
Real-Time Process |
LTI |
Implant, Intragastric For Morbid Obesity |
Unknown |
| 2025-07-11 |
N970003-S300 |
ALTRUA 2 (Models S701, S702, S722); ESSENTIO (Models L100, L101, L121); PROPONENT (Models L200, L201, L221); ACCOLADE |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-07-01 |
N970012-S208 |
AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone |
30-Day Notice |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2025-06-26 |
P190019-S038 |
Ranger Paclitaxel-Coated PTA Balloon Catheter |
135 Review Track For 30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2025-06-25 |
P150031-S086 |
VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM |
30-Day Notice |
NHL |
— |
— |
| 2025-06-25 |
P030017-S384 |
Precision Spinal Cord Stimulator (SCS) Systems |
30-Day Notice |
LGW |
— |
— |
| 2025-06-04 |
P910073-S181 |
Endotak Lead System |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-06-04 |
P010012-S590 |
NAV 2 Quadpole LV Long Spiral; NAV 2 Quadpole LV Straight; NAV 2 Quadpole LV Short Spiral |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2025-06-03 |
P000053-S137 |
AMS 800 Artificial Urinary Sphincter (AUS) with and without lnhibiZone |
Real-Time Process |
EZY |
Device, Incontinence, Mechanical/Hydraulic |
Gastroenterology, Urology |
| 2025-05-29 |
P150031-S085 |
VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM |
Special (Immediate Track) |
NHL |
— |
— |
| 2025-05-28 |
P900056-S220 |
ROTAPRO Rotational Atherectomy System |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2025-05-28 |
P000053-S139 |
AMS 800 Artificial Urinary Sphincter (AUS) |
30-Day Notice |
EZY |
Device, Incontinence, Mechanical/Hydraulic |
Gastroenterology, Urology |
| 2025-05-28 |
N970012-S207 |
AMS 700 Inflatable Penile Prosthesis without InhibiZone |
30-Day Notice |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2025-05-22 |
P170023-S021 |
Bulkamid Urethral Bulking System |
30-Day Notice |
LNM |
Agent, Bulking, Injectable For Gastro-Urology Use |
Unknown |
| 2025-05-20 |
P900056-S219 |
ROTAPRO Rotational Atherectomy System |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2025-05-20 |
P170023-S022 |
Bulkamid Urethral Bulking System |
30-Day Notice |
LNM |
Agent, Bulking, Injectable For Gastro-Urology Use |
Unknown |
| 2025-05-20 |
P150031-S083 |
Vercise Genus, Vercise Gevia, Vercise PC, Vercise DBS Systems |
Real-Time Process |
NHL |
— |
— |
| 2025-05-05 |
P130013-S075 |
WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Closure D |
Real-Time Process |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2025-05-01 |
P980037-S094 |
AngioJet Thrombectomy System - AutoElite Console |
Normal 180 Day Track |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2025-04-25 |
P130013-S071 |
WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl |
135 Review Track For 30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2025-04-18 |
P150003-S109 |
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System; SYNERGY XD Everolimus-Eluting Platinum Chromium Coro |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2025-04-16 |
P150012-S167 |
INGEVITY+ Active Fixation |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-04-11 |
P960040-S504 |
D010 INOGEN MINI ICD VR; D011 INOGEN MINI ICD VR; D012 INOGEN MINI ICD DR; D013 INOGEN MINI ICD DR; D020 DYNAGEN MI |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-04-11 |
P190006-S098 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2025-04-11 |
P180046-S098 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2025-04-11 |
P150012-S166 |
Essentio MRI SR; Essentio MRI DR; L131 Essentio MRI EL DR; Proponent; Accolade MRI SR; Accolade MRI DR; Accolade MRI EL |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-04-11 |
P010012-S589 |
Inogen CRT-D; Inogen X4 CRT-D; Dynagen CRT-D; Dynagen X4 CRT-D |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2025-04-11 |
N970003-S299 |
Essentio SR; Essentio DR; Essentio EL DR; Proponent SR; Proponent DR; Proponent EL DR; Accolade SR; Accolade DR; Accolad |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-04-03 |
P150003-S108 |
SYNERGY XD and SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2025-04-02 |
P190006-S089 |
Axonics Sacral Neuromodulation System |
135 Review Track For 30-Day Notice |
QON |
— |
— |
| 2025-04-02 |
P180046-S089 |
Axonics Sacral Neuromodulation System |
135 Review Track For 30-Day Notice |
EZW |
— |
— |
| 2025-03-31 |
P920047-S136 |
RHYTHMIA HDx Ablation Connection Box (for INTELLAGEN) |
30-Day Notice |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2025-03-31 |
P150005-S087 |
RHYTHMIA HDx Ablation Connection Box (for INTELLAGEN); Rhythmia HDx Ablation Connection Box (Maestro);RHYTHMIA HDx |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2025-03-31 |
P020025-S145 |
RHYTHMIA HDx Ablation Connection Box (for INTELLAGEN); Rhythmia HDx Ablation Connection Box (Maestro) |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2025-03-21 |
P220032-S010 |
Boston Scientific Cardiac Cryoablation System |
Special (Immediate Track) |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2025-03-20 |
P920047-S135 |
IntellaNav ST Ablation Catheter |
30-Day Notice |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2025-03-20 |
P020025-S144 |
IntellaNav MiFi XP Ablation Catheter |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2025-03-18 |
N970012-S206 |
AMS 700 Inflatable Penile Prosthesis with and without InhibiZone |
Real-Time Process |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2025-03-17 |
P150031-S082 |
Deep Brain Stimulation (DBS) |
Real-Time Process |
NHL |
— |
— |
| 2025-03-17 |
P030017-S382 |
Spinal Cord Stimulation (SCS) |
Real-Time Process |
LGW |
— |
— |
| 2025-03-17 |
P030017-S381 |
WaveWriter Alpha SCS System, WaveWriter Alpha Prime SCS System |
Normal 180 Day Track |
LGW |
— |
— |
| 2025-03-09 |
P230035-S003 |
AGENT Paclitaxel-Coated Balloon Catheter |
135 Review Track For 30-Day Notice |
OOB |
Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter |
Unknown |
| 2025-03-05 |
P170023-S020 |
Bulkamid Urethral Bulking System |
30-Day Notice |
LNM |
Agent, Bulking, Injectable For Gastro-Urology Use |
Unknown |
| 2025-02-12 |
P190019-S037 |
Ranger Paclitaxel-Coated PTA Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2025-02-10 |
P220032-S009 |
SMARTFREEZE Cryo-Cable |
30-Day Notice |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2025-02-07 |
P190006-S097 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2025-02-07 |
P180046-S097 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2025-02-05 |
P950020-S146 |
WOLVERINE Coronary Cutting Balloon |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2025-02-05 |
P150031-S076 |
Vercise DBS Controller |
Normal 180 Day Track |
NHL |
— |
— |
| 2025-02-05 |
P150003-S107 |
SYNERGYXD Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY MEGATRON Everolimus-Eluting Platinum Chr |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2025-02-03 |
P190006-S094 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
QON |
— |
— |
| 2025-02-03 |
P180046-S094 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
EZW |
— |
— |
| 2025-01-27 |
P190006-S079 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
QON |
— |
— |
| 2025-01-27 |
P180046-S079 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
EZW |
— |
— |
| 2025-01-27 |
P150003-S105 |
SYNERGY XD Everolimus Eluting Platinum Chromium Coronary Stent System, SYNERGY SHIELD Everolimus Eluting Platinum Chromi |
Panel Track |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2025-01-23 |
P000053-S136 |
AMS 800 Artificial Urinary Sphincter, AMS 800 Artificial Urinary Sphincter with InhibiZone |
30-Day Notice |
EZY |
Device, Incontinence, Mechanical/Hydraulic |
Gastroenterology, Urology |
| 2025-01-21 |
P190006-S096 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2025-01-21 |
P180046-S096 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2025-01-17 |
P900056-S218 |
Rotawire Guidewire, ROTAWIRE Drive Guidewire |
135 Review Track For 30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2025-01-16 |
P190006-S095 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2025-01-16 |
P180046-S095 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2025-01-14 |
P230035-S005 |
AGENT Paclitaxel-Coated Balloon Catheter |
30-Day Notice |
OOB |
Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter |
Unknown |
| 2025-01-14 |
P190019-S036 |
Ranger Paclitaxel-Coated PTA Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2025-01-14 |
P180011-S065 |
ELUVIA Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2025-01-14 |
P150003-S106 |
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Co |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2025-01-14 |
P110010-S213 |
PROMUS Element PLUS, PREMIER, ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2025-01-08 |
P150031-S081 |
Vercise Deep Brain Stimulation (DBS) Systems |
30-Day Notice |
NHL |
— |
— |
| 2025-01-08 |
P030017-S380 |
Precision Spinal Cord Stimulator (SCS) Systems |
30-Day Notice |
LGW |
— |
— |
| 2025-01-02 |
P190006-S084 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
QON |
— |
— |
| 2025-01-02 |
P180046-S084 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
EZW |
— |
— |
| 2024-12-23 |
P150031-S080 |
Vercise Genus Deep Brain Stimulation System |
Special (Immediate Track) |
NHL |
— |
— |
| 2024-12-18 |
P150031-S079 |
Vercise Deep Brain Stimulation (DBS) Systems |
30-Day Notice |
NHL |
— |
— |
| 2024-12-18 |
P150012-S164 |
IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-12-18 |
P150003-S100 |
SYNERGY XD Everolimus Eluting Platinum Chromium Coronary Stent System and SYNERGY SHIELD Everolimus Eluting Platinum Chr |
Normal 180 Day Track No User Fee |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2024-12-18 |
P140026-S031 |
ENROUTE® Transcarotid Stent System |
30-Day Notice |
NIM |
— |
— |
| 2024-12-18 |
P030017-S379 |
Precision Spinal Cord Stimulator (SCS) Systems |
30-Day Notice |
LGW |
— |
— |
| 2024-12-18 |
N970003-S298 |
PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-12-17 |
P180011-S064 |
ELUVIA Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2024-12-17 |
P140028-S082 |
INNOVA Self Expanding Stent System |
30-Day Notice |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2024-12-17 |
N970012-S205 |
AMS 700 Inflatable Penile Prosthesis with and without InhibiZone |
30-Day Notice |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2024-12-11 |
P190019-S034 |
Ranger Paclitaxel-Coated PTA Balloon Catheter |
Real-Time Process |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2024-12-11 |
P190019-S031 |
Ranger Paclitaxel-Coated PTA Balloon Catheter |
Normal 180 Day Track No User Fee |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2024-12-10 |
P950020-S144 |
Wolverine Coronary Cutting Balloon (Monorail) |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2024-12-03 |
P910073-S179 |
RELIANCE 4-FRONT |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-11-27 |
P190006-S093 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2024-11-27 |
P180046-S093 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2024-11-26 |
P180011-S063 |
Eluvia Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2024-11-26 |
P140028-S081 |
Innova Vascular Self Expanding Stent with Delivery System |
30-Day Notice |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2024-11-26 |
P110035-S073 |
EPIC SELF-EXPANDING NITINOL STENT SYSTEM |
30-Day Notice |
NIO |
Stent, Iliac |
Unknown |
| 2024-11-25 |
P960040-S503 |
D010 INOGEN MINI ICD VR, D011 INOGEN MINI ICD VR, D012 INOGEN MINI ICD DR, D013 INOGEN MINI ICD DR, D020 DYNAGEN MINI IC |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-11-25 |
P190006-S092 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
QON |
— |
— |
| 2024-11-25 |
P180046-S092 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
EZW |
— |
— |
| 2024-11-25 |
P150012-S163 |
L110 ESSENTIO MRI SR, L111 ESSENTIO MRI DR, L131 ESSENTIO MRI EL DR, L210 PROPONENT, L211 PROPONENT, L231 PROPONENT, L31 |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-11-25 |
P110042-S201 |
A209 SICD Gen 2, A219 SICD MRI |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-11-25 |
P010012-S588 |
G124 MOMENTUM CRT-D, G125 MOMENTUM CRT-D, G126 MOMENTUM CRT-D, G128 MOMENTUM, G138 MOMENTUM X4 CRT-D, G140 INOGEN CRT-D, |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2024-11-25 |
N970003-S297 |
L100 ESSENTIO SR, L101 ESSENTIO DR, L121 ESSENTIO EL DR, L200 PROPONENT SR, L201 PROPONENT DR, L221 PROPONENT EL DR, L30 |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-11-22 |
P950020-S145 |
WOLVERINE Coronary Cutting Balloon® |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2024-11-19 |
P170023-S019 |
Bulkamid Urethral Bulking System |
30-Day Notice |
LNM |
Agent, Bulking, Injectable For Gastro-Urology Use |
Unknown |
| 2024-11-19 |
P050019-S042 |
Carotid Wallstent Monorail Endoprosthesis |
Normal 180 Day Track No User Fee |
NIM |
— |
— |
| 2024-11-14 |
P150005-S086 |
Blazer Open Irrigated Ablation Catheter, IntellaNav Open Irrigated Ablation Catheter, IntellaNav MiFi Open Irrigated Abl |
Real-Time Process |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2024-11-13 |
P150031-S065 |
Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System |
Normal 180 Day Track |
NHL |
— |
— |
| 2024-11-08 |
P150012-S162 |
INGEVITY+ |
Normal 180 Day Track No User Fee |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-11-07 |
P910073-S180 |
LD SEN DF4 IB IR PF DC, LD SEN DF4 IB IR PF SC, LD SEN DF4 IB IR PF SC, LD SEN DF4 IB IR PF DC, LD SEN DF4 IB IR AF SC, |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-11-07 |
P190019-S032 |
Ranger Paclitaxel-Coated PTA Balloon Catheter |
Normal 180 Day Track |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2024-11-07 |
P150031-S078 |
Vercise Deep Brain Stimulation (DBS) Systems |
30-Day Notice |
NHL |
— |
— |
| 2024-11-07 |
P110042-S200 |
EMBLEM S-ICD ELECTRODE 45 CM 3501 |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-11-07 |
P030017-S378 |
Precision Spinal Cord Stimulator (SCS) Systems |
30-Day Notice |
LGW |
— |
— |
| 2024-11-07 |
P010012-S587 |
NAV 2 Quadpole LV Straight 86CM 4671, NAV 2 Quadpole LV Straight 95CM 4672, NAV 2 Quadpole LV Short Spiral 86CM 4674, N |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2024-11-05 |
P190006-S091 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2024-11-05 |
P180046-S091 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2024-11-01 |
P150012-S160 |
ACCOLADE |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-11-01 |
P130013-S072 |
WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2024-11-01 |
N970003-S295 |
ACCOLADE |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-10-28 |
P180011-S062 |
Eluvia Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2024-10-25 |
P140026-S030 |
ENROUTE® Transcarotid Stent System |
30-Day Notice |
NIM |
— |
— |
| 2024-10-23 |
P960040-S502 |
VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-10-23 |
P150012-S161 |
IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-10-23 |
P110042-S199 |
SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-10-23 |
P010012-S586 |
CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2024-10-23 |
N970003-S296 |
PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-10-21 |
P190006-S090 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2024-10-21 |
P180046-S090 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2024-10-18 |
P220032-S004 |
SMARTFREEZETM Catheter Extension Cable |
Normal 180 Day Track No User Fee |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2024-10-18 |
P180011-S061 |
Eluvia Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2024-10-08 |
P000053-S130 |
AMS 800 Artificial Urinary Sphincter (with and without InhibiZone) |
Normal 180 Day Track |
EZY |
Device, Incontinence, Mechanical/Hydraulic |
Gastroenterology, Urology |
| 2024-10-01 |
P150003-S102 |
SYNERGY SHIELD Monorail Everolimus-Eluting Platinum Chromium Coronary Stent System, YNERGY MEGATRON Monorail Everolimu |
Real-Time Process |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2024-09-25 |
P110042-S198 |
EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) Pulse Generator (PG) |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-09-24 |
P200029-S010 |
TheraSphere |
Normal 180 Day Track No User Fee |
NAW |
Microspheres Radionuclide |
Unknown |
| 2024-09-23 |
P130013-S070 |
WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Closure D |
Real-Time Process |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2024-09-18 |
P190006-S088 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2024-09-18 |
P180046-S088 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2024-09-16 |
P190006-S080 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track No User Fee |
QON |
— |
— |
| 2024-09-16 |
P180046-S080 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track No User Fee |
EZW |
— |
— |
| 2024-09-16 |
P150012-S158 |
INGEVITY + Leads - Active Fixation |
Normal 180 Day Track |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-09-12 |
P220032-S008 |
POLARx and POLARxFIT Cryoablation Catheters |
30-Day Notice |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2024-09-04 |
P190006-S087 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2024-09-04 |
P180046-S087 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2024-09-04 |
P150031-S077 |
Vercise Genus Deep Brain Stimulation (DBS) Systems |
30-Day Notice |
NHL |
— |
— |
| 2024-09-03 |
P170023-S018 |
Bulkamid Urethral Bulking System |
30-Day Notice |
LNM |
Agent, Bulking, Injectable For Gastro-Urology Use |
Unknown |
| 2024-08-28 |
P010012-S585 |
Cardiac Resynchronization Therapy Defibrillator (CRT-D) |
Normal 180 Day Track |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2024-08-23 |
P220032-S007 |
POLARx FIT Cryoablation Balloon Catheters |
30-Day Notice |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2024-08-16 |
P150003-S104 |
SYNERGY , SYNERGY XD, SYNERGY MEGATRON and SYNERGY Shield Everolimus-Eluting Platinum Chromium Coronary Stent System |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2024-08-15 |
P110042-S197 |
EMBLEM SICD Lead |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-08-06 |
P150031-S073 |
Vercise Genus Deep Brain Stimulation (DBS) System |
Real-Time Process |
NHL |
— |
— |
| 2024-08-05 |
P980037-S093 |
AngioJet Ultra 5000A Console |
Real-Time Process |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2024-08-02 |
P190006-S078 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
QON |
— |
— |
| 2024-08-02 |
P180046-S078 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
EZW |
— |
— |
| 2024-07-30 |
P220032-S005 |
POLARx Short Tip (ST) Cryoablation Balloon Catheter, POLARx Long Tip (LT) Cryoablation Balloon Catheter, POLARx FIT S |
Real-Time Process |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2024-07-30 |
P170023-S017 |
Bulkamid Urethral Bulking System |
30-Day Notice |
LNM |
Agent, Bulking, Injectable For Gastro-Urology Use |
Unknown |
| 2024-07-26 |
P950020-S143 |
SYNERGY MEGATRON Monorail Everolimus-Eluting Platinum Chromium Coronary Stent System |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2024-07-26 |
P150031-S075 |
Vercise Genus Deep Brain Stimulation (DBS) Systems |
30-Day Notice |
NHL |
— |
— |
| 2024-07-26 |
P150003-S101 |
SYNERGY, XD, SHIELD and MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2024-07-26 |
P030017-S376 |
WaterWriter Alpha Spinal Cord Stimulator (SCS) Systems |
30-Day Notice |
LGW |
— |
— |
| 2024-07-25 |
P190006-S086 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2024-07-25 |
P180046-S086 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2024-07-23 |
P190019-S033 |
Ranger Paclitaxel-Coated Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2024-07-22 |
P010012-S581 |
MT PAS ACUITY X4 |
Normal 180 Day Track No User Fee |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2024-07-18 |
P960040-S500 |
Latitude NXT Patient Management System (TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-07-18 |
P910077-S194 |
Latitude NXT Patient Management System |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-07-18 |
P150012-S157 |
Latitude NXT Patient Management System (INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-07-18 |
P110042-S195 |
Latitude NXT Patient Management System (EMBLEM S-ICD) |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-07-18 |
P010012-S582 |
Latitude NXT Patient Management System (COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, |
Real-Time Process |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2024-07-18 |
N970003-S293 |
Latitude NXT Patient Management System (ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, INSIGNIA, AL |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-07-17 |
P920047-S133 |
INTELLAGEN Cardiac Ablation System |
Normal 180 Day Track |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2024-07-17 |
P150005-S079 |
INTELLAGEN Cardiac Ablation System |
Normal 180 Day Track |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2024-07-17 |
P020025-S141 |
INTELLAGEN Cardiac Ablation System |
Normal 180 Day Track |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2024-07-16 |
P190006-S085 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2024-07-16 |
P180046-S085 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2024-07-16 |
P150003-S099 |
Synergy Everolimus-eluting Platinum Chromium Coronary Stent System |
Normal 180 Day Track No User Fee |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2024-07-12 |
P150005-S085 |
IntellaNav StablePoint Catheter and Open-Irrigated Catheter |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2024-07-05 |
P220032-S006 |
POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories |
Normal 180 Day Track No User Fee |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2024-06-28 |
P230035-S002 |
AGENT Paclitaxel-Coated Balloon Catheter |
Normal 180 Day Track No User Fee |
OOB |
Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter |
Unknown |
| 2024-06-27 |
P980033-S066 |
Wallstent Venous Endoprosthesis with Unistep Plus Delivery System |
30-Day Notice |
QKJ |
Stent, Central Venous |
Unknown |
| 2024-06-27 |
P930031-S076 |
Wallstent TIPS Endoprosthesis with Unistep Plus Delivery System |
30-Day Notice |
MIR |
Shunt, Portosystemic, Endoprosthesis |
Unknown |
| 2024-06-25 |
P150005-S084 |
INTELLANAV STABLEPOINT Ablation Catheter |
Real-Time Process |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2024-06-21 |
P150031-S074 |
Vercise Deep Brain Stimulation (DBS) Systems |
30-Day Notice |
NHL |
— |
— |
| 2024-06-21 |
P030017-S375 |
Precision Spional Cord Stimulator (SCS) Systems |
30-Day Notice |
LGW |
— |
— |
| 2024-06-14 |
P130013-S069 |
WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2024-06-05 |
P900056-S217 |
Rotablator and ROTAPRO Rotational Atherectomy System |
Real-Time Process |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2024-06-04 |
P150012-S156 |
ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-06-04 |
N970003-S292 |
ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-05-31 |
P140008-S026 |
ORBERA Intragastric Balloon |
30-Day Notice |
LTI |
Implant, Intragastric For Morbid Obesity |
Unknown |
| 2024-05-30 |
N970012-S204 |
AMS 700 Inflatable Penile Prosthesis, AMS 700 Inflatable Penile Prosthesis with InhibiZone |
30-Day Notice |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2024-05-29 |
P960040-S501 |
D010 INOGEN MINI ICD VR, D011 INOGEN MINI ICD VR, D012 INOGEN MINI ICD DR, D013 INOGEN MINI ICD DR, D020 DYNAGEN MI |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-05-29 |
P150012-S159 |
L110 ESSENTIO MRI SR, L111 ESSENTIO MRI DR, L131 ESSENTIO MRI EL DR, L210 PROPONENT, L211 PROPONENT, L231 PROPONENT, |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-05-29 |
P110042-S196 |
A209 SICD Gen 2, A219 SICD MRI |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-05-29 |
P010012-S584 |
G124 MOMENTUM CRT-D, G125 MOMENTUM CRT-D, G126 MOMENTUM CRT-D, G128 MOMENTUM, G138 MOMENTUM X4 CRT-D, G140 INOGEN C |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2024-05-29 |
P000053-S135 |
AMS 800 Artificial Urinary Sphincter with and without InhibiZone |
30-Day Notice |
EZY |
Device, Incontinence, Mechanical/Hydraulic |
Gastroenterology, Urology |
| 2024-05-29 |
N970012-S203 |
AMS 700 Inflatable Penile Prosthesis without InhibiZone |
30-Day Notice |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2024-05-29 |
N970003-S294 |
L100 ESSENTIO SR, L101 ESSENTIO DR, L121 ESSENTIO EL DR, L200 PROPONENT SR, L201 PROPONENT DR, L221 PROPONENT EL D |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-05-24 |
P980037-S092 |
AngioJet Spiroflex Thrombectomy Set, AngioJet Spiroflex VG Thrombectomy Set |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2024-05-23 |
P000053-S134 |
AMS 800 Artificial Urinary Sphincter (with InhibiZone) |
135 Review Track For 30-Day Notice |
EZY |
Device, Incontinence, Mechanical/Hydraulic |
Gastroenterology, Urology |
| 2024-05-23 |
N970012-S202 |
AMS 700 Inflatable Penile Prosthesis (with InhibiZone) |
135 Review Track For 30-Day Notice |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2024-05-22 |
P910073-S178 |
RELIANCE 4-FRONT |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-05-22 |
P010012-S583 |
ACUITY X4 Straight, ACUITY X4 Spiral S, ACUITY X4 Spiral L |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2024-05-20 |
P180011-S059 |
ELUVIA Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2024-05-20 |
P140028-S080 |
Innova Vascular Self-Expanding Stent System |
30-Day Notice |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2024-05-14 |
P150031-S068 |
Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System |
Normal 180 Day Track |
NHL |
— |
— |
| 2024-05-08 |
P190019-S030 |
Ranger Paclitaxel-Coated PTA Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2024-05-02 |
P190006-S083 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2024-05-02 |
P180046-S083 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2024-04-30 |
P960040-S499 |
TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-04-30 |
P910077-S193 |
LATITUDE Programming System |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-04-30 |
P150012-S155 |
INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-04-30 |
P110042-S193 |
EMBLEM S-ICD |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-04-30 |
P010012-S580 |
COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA |
Real-Time Process |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2024-04-30 |
N970003-S291 |
ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, ALTRUA, INSIGNIA I, NEXUS I |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-04-29 |
P030017-S371 |
WaveWriter Alpha SCS System |
Real-Time Process |
LGW |
— |
— |
| 2024-04-24 |
P130013-S068 |
WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System and WATCHMAN FLX Pro Left Atrial Appendage |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2024-04-18 |
P130013-S067 |
WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2024-04-16 |
P130013-S065 |
WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl |
Normal 180 Day Track No User Fee |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2024-04-12 |
P190006-S081 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2024-04-12 |
P180046-S081 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2024-04-11 |
P230035-S001 |
AGENT Paclitaxel-Coated Balloon Catheter |
Normal 180 Day Track No User Fee |
OOB |
Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter |
Unknown |
| 2024-04-10 |
P190006-S082 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2024-04-10 |
P180046-S082 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2024-04-05 |
P920047-S131 |
BLAZER Solid-Tip Ablation Catheter Cable 10, BLAZER Solid-Tip Ablation Catheter Cable 3, INTELLANAV Ablation Cathet |
Normal 180 Day Track No User Fee |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2024-04-05 |
P200029-S009 |
TheraSphere |
30-Day Notice |
NAW |
Microspheres Radionuclide |
Unknown |
| 2024-04-05 |
P150005-S077 |
BLAZER OI Catheter Cable, INTELLATIP MIFI OI Cable, INTELLANAV Ablation Catheter Cable |
Normal 180 Day Track No User Fee |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2024-04-05 |
P110042-S194 |
A209 SICD Gen 2, A219 SICD MRI |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-04-05 |
P020025-S139 |
BLAZER Solid-Tip Ablation Catheter Cable 10, BLAZER Solid-Tip Ablation Catheter Cable 3, INTELLATIP MIFI XP Cable, |
Normal 180 Day Track No User Fee |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2024-04-04 |
P030017-S358 |
mySCS GO Therapy Controller App |
Normal 180 Day Track |
LGW |
— |
— |
| 2024-04-01 |
P190006-S077 |
Axonics Sacral Neuromodulation System |
Real-Time Process |
QON |
— |
— |
| 2024-04-01 |
P180046-S077 |
Axonics Sacral Neuromodulation System |
Real-Time Process |
EZW |
— |
— |
| 2024-03-28 |
P910073-S177 |
Lead Repair Kit Model 6946 |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-03-27 |
P050019-S041 |
Carotid WALLSTENT Monorail Endoprosthesis |
30-Day Notice |
NIM |
— |
— |
| 2024-03-26 |
P140026-S029 |
ENROUTE Transcarotid Stent System |
30-Day Notice |
NIM |
— |
— |
| 2024-03-25 |
P150005-S083 |
Blazer and IntellaNav/MiFi Open-Irrigated Ablation Catheters |
Normal 180 Day Track No User Fee |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2024-03-22 |
P190019-S029 |
Ranger Paclitaxel-Coated Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2024-03-19 |
P190019-S028 |
Ranger Paclitaxel-Coated PTA Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2024-03-18 |
P220032-S003 |
Cryo Cable |
30-Day Notice |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2024-03-15 |
P900056-S216 |
Rotablator and ROTAPRO Rotational Atherectomy System |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2024-03-13 |
P980037-S091 |
AngioJet Rheolythic Thrombectomy Catheter |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2024-03-13 |
P980033-S065 |
Wallstent Venous Endoprosthesis with Unistep Plus Delivery System |
30-Day Notice |
QKJ |
Stent, Central Venous |
Unknown |
| 2024-03-13 |
P930031-S075 |
Wallstent TIPS Endoprosthesis with Unistep Plus Delivery System |
30-Day Notice |
MIR |
Shunt, Portosystemic, Endoprosthesis |
Unknown |
| 2024-03-13 |
P900056-S215 |
Rotablator Rotational Atherectomy System |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2024-03-13 |
P150031-S071 |
Vercise Deep Brain Stimulation (DBS) Systems (Vercise Genus R32, Vercise Genus R16) |
30-Day Notice |
NHL |
— |
— |
| 2024-03-13 |
P140028-S079 |
Innova Vascular Self-Expanding Stent with Delivery System |
30-Day Notice |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2024-03-13 |
P110035-S072 |
Epic Vascular Self-Expanding Stent System |
30-Day Notice |
NIO |
Stent, Iliac |
Unknown |
| 2024-03-13 |
P090003-S056 |
Express LD Iliac Premounted Stent System |
30-Day Notice |
NIO |
Stent, Iliac |
Unknown |
| 2024-03-13 |
P030017-S373 |
Precision Spinal Cord Stimulator (SCS) Systems (WaveWriter Alpha, WaveWriter Alpha 16) |
30-Day Notice |
LGW |
— |
— |
| 2024-03-12 |
P150005-S082 |
Metriq Tubing Set and Metriq Footswitch |
Real-Time Process |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2024-03-08 |
P050019-S040 |
Carotid Wallstent Monorail Endoprosthesis |
Normal 180 Day Track No User Fee |
NIM |
— |
— |
| 2024-03-07 |
P190019-S027 |
Ranger-Over-The-Wire Paclitaxel Coated Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2024-02-29 |
P230035 |
AGENT Paclitaxel-Coated Balloon Catheter |
Original |
OOB |
Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter |
Unknown |
| 2024-02-29 |
P150031-S064 |
Vercise PC DBS System, Vercise Gervia DBS System, Vercise Genus DBS System |
Panel Track |
NHL |
— |
— |
| 2024-02-26 |
P150031-S070 |
Vercise Deep Brain Stimulation (DBS) Systems |
30-Day Notice |
NHL |
— |
— |
| 2024-02-26 |
P150005-S074 |
INTELLANAV STABLEPOINT Ablation Catheter & Force Sensing System on the RHYTHMIA HDX Mapping System |
Panel Track |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2024-02-26 |
P030017-S372 |
Precision Spinal Cord Stimulator (SCS) Systems |
30-Day Notice |
LGW |
— |
— |
| 2024-02-20 |
P980033-S064 |
Wallstent Venous Endoprosthesis with Unistep Plus Delivery System |
135 Review Track For 30-Day Notice |
QKJ |
Stent, Central Venous |
Unknown |
| 2024-02-20 |
P930031-S074 |
Wallstent TIPS Endoprosthesis with Unistep Plus Delivery System |
135 Review Track For 30-Day Notice |
MIR |
Shunt, Portosystemic, Endoprosthesis |
Unknown |
| 2024-02-16 |
P150005-S081 |
INTELLANAV MIFI Open-Irrigated Ablation Catheters |
Real-Time Process |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2024-02-16 |
P020025-S143 |
IntellaNav XP and IntellaNav MiFi XP Ablation Catheters |
Real-Time Process |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2024-02-14 |
P130013-S066 |
WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2024-02-08 |
P190006-S076 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
QON |
— |
— |
| 2024-02-08 |
P180046-S076 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
EZW |
— |
— |
| 2024-02-07 |
P200029-S008 |
TheraSphereTM Y-90 Glass Microspheres System |
30-Day Notice |
NAW |
Microspheres Radionuclide |
Unknown |
| 2024-02-06 |
P200029-S006 |
TheraSphere |
Real-Time Process |
NAW |
Microspheres Radionuclide |
Unknown |
| 2024-02-05 |
P130013-S064 |
WATCHMAN FLX Left Atrial Appendage (LAA) Closure Technology, WATCHMAN FLX Left Atrial Appendage Closure Device with Deli |
Real-Time Process |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2024-02-05 |
P030017-S363 |
Spectra WaveWriter SCS System, WaveWriter Alpha SCS System, WaveWriter Alpha Prime SCS System |
Panel Track |
LGW |
— |
— |
| 2024-01-25 |
P030017-S370 |
Precision Spinal Cord Stimulator (SCS) Systems |
30-Day Notice |
LGW |
— |
— |
| 2024-01-24 |
P030017-S354 |
Infinion Pro Leads |
Normal 180 Day Track |
LGW |
— |
— |
| 2024-01-19 |
P910073-S175 |
Lead Repair Kit Model 6946 |
Normal 180 Day Track No User Fee |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-01-19 |
P830060-S090 |
Medical Adhesive Model 6517 |
Normal 180 Day Track No User Fee |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-01-19 |
P180011-S055 |
ELUVIA Drug-Eluting Vascular Stent System |
Normal 180 Day Track No User Fee |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2024-01-19 |
P150003-S096 |
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Co |
Normal 180 Day Track No User Fee |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2024-01-10 |
P150031-S066 |
Vercise Genus Deep Brain Stimulation (DBS) System |
Real-Time Process |
NHL |
— |
— |
| 2024-01-09 |
P150031-S069 |
Vercise Deep Brain Stimulation (DBS) Systems |
30-Day Notice |
NHL |
— |
— |
| 2024-01-09 |
P030017-S369 |
Precision Spinal Cord Stimulator (SCS) Systems |
30-Day Notice |
LGW |
— |
— |
| 2024-01-03 |
P010012-S579 |
Butylated Hydroxytoluene (BHT) |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2023-12-29 |
P150031-S067 |
Vercise Deep Brain Stimulation (DBS) Systems |
30-Day Notice |
NHL |
— |
— |
| 2023-12-29 |
P150012-S154 |
Essentio MRI SR, Essentio MRI DR, Essentio MRI EL DR, Proponent MRI SR, Proponent MRI DR, Accolade MRI SR, Accoldae MRI |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-12-29 |
P030017-S368 |
Precision Spinal Cord Stimulator (SCS) Systems |
30-Day Notice |
LGW |
— |
— |
| 2023-12-29 |
N970003-S290 |
Essentio SR, Essento DR, Proponent Dr, Proponent El Dr, Accolade Sr, Accolade Dr, Accolade El Dr, Altrua 2 Sr, Altrua 2 |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-12-23 |
P130013-S060 |
WATCHMAN FLX Left Atrial Appendage (LAA) Closure Technology, WATCHMAN FLX Left Atrial Appendage Closure Device with Deli |
Real-Time Process |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2023-12-18 |
P200029-S007 |
TheraSphere |
30-Day Notice |
NAW |
Microspheres Radionuclide |
Unknown |
| 2023-12-18 |
P170023-S016 |
Bulkamid Urethral Bulking System |
30-Day Notice |
LNM |
Agent, Bulking, Injectable For Gastro-Urology Use |
Unknown |
| 2023-12-14 |
P140008-S025 |
ORBERA Intragastric Balloon (IGB) System, Endoline Punc |
Normal 180 Day Track |
LTI |
Implant, Intragastric For Morbid Obesity |
Unknown |
| 2023-12-13 |
P110042-S189 |
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-12-12 |
P980003-S097 |
Chilli Cooled Rf Ablation System |
30-Day Notice |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2023-12-12 |
P950020-S142 |
WOLVERINE Coronary Cutting Balloon |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2023-12-12 |
P920047-S134 |
Blazer II Cardiac Ablation System and Cable |
30-Day Notice |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2023-12-12 |
P900056-S213 |
ROTAPRO Rotational Atherectomy System |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2023-12-12 |
P900056-S212 |
Rotablator Rotational Atherectomy System |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2023-12-12 |
P220032-S002 |
POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories |
30-Day Notice |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2023-12-12 |
P190019-S025 |
Ranger Paclitaxel-Coated PTA Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2023-12-12 |
P150005-S080 |
Blazer Open-Irrigated Ablation Catheter |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2023-12-12 |
P130030-S077 |
REBEL Platinum Chromium Coronary Stent System Monorail and Over the Wire |
30-Day Notice |
MAF |
Stent, Coronary |
Unknown |
| 2023-12-12 |
P110010-S212 |
PROMUS Element Plus and Promus PREMIER and Promus ELITE Everolimus-Eluting Stent System |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2023-12-12 |
P060006-S109 |
Express® SD Renal Monorail Premounted Stent System |
30-Day Notice |
NIN |
Stent, Renal |
Unknown |
| 2023-12-12 |
P020025-S142 |
Blazer II XP Cardiac Ablation Catheter and Cable |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2023-12-11 |
P000053-S133 |
AMS 800 Artificial Urinary Sphincter (AUS) |
30-Day Notice |
EZY |
Device, Incontinence, Mechanical/Hydraulic |
Gastroenterology, Urology |
| 2023-12-11 |
N970012-S201 |
AMS 700 Inflatable Penile Prosthesis (IPP |
30-Day Notice |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2023-12-08 |
P110042-S192 |
EMBLEM S-ICD VI Electrode (Lead) |
Normal 180 Day Track No User Fee |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-12-06 |
P900056-S214 |
Rotablatorand ROTAPRO Rotational Atherectomy System |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2023-12-04 |
P130013-S063 |
WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2023-11-30 |
P150031-S062 |
Vercise Genus DBS System |
Real-Time Process |
NHL |
— |
— |
| 2023-11-28 |
P190006-S075 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2023-11-28 |
P180046-S075 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2023-11-28 |
P010012-S578 |
Fourier-Transform Infrared Spectroscopy (FTIR) |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2023-11-24 |
P190019-S026 |
Ranger Paclitaxel-Coated PTA Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2023-11-22 |
P000053-S132 |
AMS 800 Artificial Urinary Sphincter (AUS) with and without lnhibiZone |
30-Day Notice |
EZY |
Device, Incontinence, Mechanical/Hydraulic |
Gastroenterology, Urology |
| 2023-11-22 |
N970012-S200 |
AMS 700 Implantable Penile Prosthesis without lnhibiZone |
30-Day Notice |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2023-11-21 |
P960040-S498 |
INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI ICD DR, MOMENTUM EL ICD VR, MOMENTUM EL |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-11-21 |
P110042-S191 |
SICD Gen 2, SICD MRI |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-11-21 |
P010012-S577 |
MOMENTUM CRT-D, MOMENTUM, MOMENTUM X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, DYNAGEN CRT-D, DYNAGEN X4 CRT-D, VIGIL |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2023-11-17 |
P220032-S001 |
POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories |
Normal 180 Day Track No User Fee |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2023-11-15 |
P960040-S493 |
HeartLogic |
Normal 180 Day Track No User Fee |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-11-15 |
P180011-S058 |
Eluvia Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2023-11-15 |
P140028-S078 |
Innova Vascular Self-Expanding Stent System |
30-Day Notice |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2023-11-15 |
P110035-S071 |
EPIC Self Expanding Stent System |
30-Day Notice |
NIO |
Stent, Iliac |
Unknown |
| 2023-11-15 |
P010012-S571 |
HeartLogic |
Normal 180 Day Track No User Fee |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2023-11-14 |
N970012-S197 |
AMS 700 Inflatable Penile Prosthesis (with and without InhibiZone) |
Normal 180 Day Track |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2023-11-09 |
P130013-S062 |
WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2023-11-06 |
P030017-S365 |
WaveWriter Alpha Spinal Cord Stimulator (SCS) System |
Real-Time Process |
LGW |
— |
— |
| 2023-10-31 |
P130013-S059 |
WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System |
Normal 180 Day Track No User Fee |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2023-10-30 |
P950020-S141 |
FLEXATOME CUTTING BALLOON |
Real-Time Process |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2023-10-25 |
P150031-S063 |
Vercise Deep Brain Stimulation (DBS) Systems |
30-Day Notice |
NHL |
— |
— |
| 2023-10-25 |
P030017-S367 |
Precision Spinal Cord Stimulator (SCS) Systems |
30-Day Notice |
LGW |
— |
— |
| 2023-10-24 |
P910073-S174 |
Lead Repair Kit Model 6946 |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-10-23 |
P190006-S071 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
QON |
— |
— |
| 2023-10-23 |
P180046-S071 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
EZW |
— |
— |
| 2023-10-19 |
P010012-S570 |
Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) |
Normal 180 Day Track No User Fee |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2023-10-18 |
P960040-S497 |
INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI ICD DR, MOMENTUM EL ICD VR, MOMENTUM EL |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-10-18 |
P150012-S152 |
ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, ACCOLADE MRI EL |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-10-18 |
P110042-S190 |
SICD Gen 2, SICD MRI |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-10-18 |
P010012-S576 |
MOMENTUM CRT-D, MOMENTUM, MOMENTUM X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, DYNAGEN CRT-D, DYNAGEN X4 CRT-D, VIGIL |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2023-10-18 |
N970003-S289 |
ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR, |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-10-17 |
P150003-S098 |
SYNERGY SHIELD Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chrom |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2023-10-16 |
P140026-S028 |
ENROUTE® Transcarotid Stent System |
30-Day Notice |
NIM |
— |
— |
| 2023-10-13 |
P150012-S150 |
INGEVITY and INGEVITY+TM active leads |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-10-11 |
P190006-S074 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2023-10-11 |
P180046-S074 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2023-10-10 |
P150031-S060 |
Vercise Genus DBS Systems, Vercise Gevia DBS System, Vercise PC DBS System |
Real-Time Process |
NHL |
— |
— |
| 2023-10-06 |
P150012-S151 |
PG ACCOLADE MRI SR SL US, PG ACCOLADE MRI DR SL US, PG ACCOLADE MRI DR EL US, PG PROPONENT MRI SR SL US, PG PROPONENT MR |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-10-06 |
N970003-S288 |
PG PROPONENT SR SL US, PG PROPONENT DR SL US, PG PROPONENT DR EL US, PG ACCOLADE SR SL US,PG ACCOLADE DR SL US, PG ACCOL |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-10-05 |
P190019-S023 |
Ranger-Over-The-Wire Paclitaxel Coated Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2023-10-05 |
P030017-S357 |
Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI, Spectra WaveWriter, WaveWriter A |
Panel Track |
LGW |
— |
— |
| 2023-09-28 |
P900056-S211 |
ROTAPRO and Rotalink Rotational Atherectomy System |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2023-09-27 |
P150031-S061 |
Vercise PC, Vercise Gevia, Vercise Genus Deep Brain Stimlation (DBS) Systems |
30-Day Notice |
NHL |
— |
— |
| 2023-09-27 |
P030017-S366 |
Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI, Spectra WaveWriter, WaveWri |
30-Day Notice |
LGW |
— |
— |
| 2023-09-26 |
P190006-S073 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2023-09-26 |
P180046-S073 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2023-09-22 |
P190019-S024 |
Ranger Paclitaxel-Coated PTA Balloon Catheter |
Normal 180 Day Track No User Fee |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2023-09-21 |
P180011-S056 |
Eluvia Drug Eluting Stent System |
Normal 180 Day Track No User Fee |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2023-09-20 |
N970012-S196 |
AMS 700 Inflatable Penile Prosthesis, AMS 700 Inflatable Penile Prosthesis with InhibiZone, AMS Ambicor Inflatable Pe |
Normal 180 Day Track |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2023-09-18 |
P110035-S070 |
Epic Self Expanding Stent System |
30-Day Notice |
NIO |
Stent, Iliac |
Unknown |
| 2023-09-15 |
N970012-S199 |
AMS 700 Inflatable Penile Prosthesis |
30-Day Notice |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2023-09-08 |
P150012-S149 |
LD Ingevity Plus AF IS1 |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-09-06 |
P150031-S055 |
Vercise S8 Adapter |
Normal 180 Day Track |
NHL |
— |
— |
| 2023-09-06 |
P130013-S057 |
WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System |
Normal 180 Day Track |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2023-08-31 |
P060006-S108 |
Express SD Renal |
30-Day Notice |
NIN |
Stent, Renal |
Unknown |
| 2023-08-29 |
P900056-S210 |
Rotablator, ROTAPRO Rotational Atherectomy System |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2023-08-25 |
P190006-S072 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2023-08-25 |
P180046-S072 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2023-08-17 |
P900056-S201 |
Rotaglide Lubricant |
Normal 180 Day Track |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2023-08-17 |
P150003-S097 |
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Coro |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2023-08-10 |
P050019-S039 |
Carotid WALLSTENT Monorail Endoprosthesis |
30-Day Notice |
NIM |
— |
— |
| 2023-08-08 |
P980037-S090 |
AngioJet Spiroflex Thrombectomy Set, AngioJet Spiroflex VG Thrombectomy Set |
Normal 180 Day Track No User Fee |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2023-08-08 |
P220032 |
POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories |
Original |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2023-08-04 |
P980033-S063 |
VENOUS WALLSTENT Self-Expanding Stent |
30-Day Notice |
QKJ |
Stent, Central Venous |
Unknown |
| 2023-08-04 |
P930031-S073 |
WALLSTENT Endoprosthesis |
30-Day Notice |
MIR |
Shunt, Portosystemic, Endoprosthesis |
Unknown |
| 2023-08-03 |
P960004-S104 |
ID/SN Label |
30-Day Notice |
NVN |
— |
— |
| 2023-08-03 |
P950020-S140 |
WOLVERINE Coronary Cutting Balloon® |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2023-07-27 |
P980003-S096 |
Chilli Cooled Rf Ablation System |
30-Day Notice |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2023-07-27 |
P950020-S139 |
WOLVERINE Coronary Cutting Balloon |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2023-07-27 |
P920047-S132 |
Blazer II Cardiac Ablation System and Cable |
30-Day Notice |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2023-07-27 |
P900056-S209 |
Rotablator Rotational Atherectomy System |
30-Day Notice |
— |
— |
— |
| 2023-07-27 |
P190019-S022 |
Ranger Paclitaxel-Coated PTA Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2023-07-27 |
P150005-S078 |
Blazer Open-Irrigated Ablation Catheter |
30-Day Notice |
— |
— |
— |
| 2023-07-27 |
P130030-S076 |
REBEL Platinum Chromium Coronary Stent System Monorail and Over the Wire |
30-Day Notice |
MAF |
Stent, Coronary |
Unknown |
| 2023-07-27 |
P110010-S211 |
PROMUS Element Plus and Promus PREMIER and Promus ELITE Everolimus-Eluting Stent System |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2023-07-27 |
P060006-S107 |
Express® SD Renal Monorail Premounted Stent System |
30-Day Notice |
NIN |
Stent, Renal |
Unknown |
| 2023-07-27 |
P020025-S140 |
Blazer II XP Cardiac Ablation Catheter and Cable |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2023-07-26 |
P200029-S005 |
TheraSphere |
30-Day Notice |
NAW |
Microspheres Radionuclide |
Unknown |
| 2023-07-21 |
P960040-S496 |
ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-07-21 |
P960006-S056 |
Accessory, Stabilizer |
30-Day Notice |
NVN |
— |
— |
| 2023-07-21 |
P960004-S105 |
FINELINE® II Sterox, FINELINE® II EZ Sterox, ACC SUP STABLZR 6220 US, ACC SUP STABLZR 6221 US |
30-Day Notice |
NVN |
— |
— |
| 2023-07-21 |
P930035-S034 |
Accessory, Wrench |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-07-21 |
P910077-S192 |
Accessory, Cap, Accessory, Plug |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-07-21 |
P910073-S173 |
Lead Repair Kit, ENDOTAK RELIANCE® S, ENDOTAK RELIANCE®, ENDOTAK RELIANCE® SG, ENDOTAK RELIANCE® G, RELIANCE 4-FRONT, A |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-07-21 |
P830060-S089 |
Accessory, Cap, Accessory, Sleeve, Accessory, Wrench Torque BI |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-07-21 |
P150012-S148 |
ACUITY Stylet, Straight 0.013, 45cm, ACUITY Stylet, Straight 0.013, 52cm, ACUITY Stylet, Straight 0.013, 59cm, ACUITY St |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-07-21 |
P110042-S188 |
EMBLEM S-ICD, EMBLEM MRI S-ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-07-21 |
P010012-S575 |
ACUITY Spiral, Accessory, Slit Suture Sleeve, ACUITY X4 Straight, ACUITY X4 Spiral S, ACUITY X4 Spiral L, Slit Sutu |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2023-07-21 |
N970003-S287 |
- ESSENTIO SR, ESSENTIO DR, SSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-07-20 |
P960040-S495 |
ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM EL ICD DR, VIGILANT EL ICD VR |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-07-20 |
P140026-S027 |
ENROUTE Transcarotid Stent System |
Normal 180 Day Track No User Fee |
NIM |
— |
— |
| 2023-07-20 |
P110042-S187 |
S-ICD GEN 2 A209, S-ICD EMBLEM MRI A219 |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-07-20 |
P010012-S574 |
MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, VIGILANT CRT-D, VIGILANT X4 CRT-D, RESONATE CRT- |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2023-07-17 |
P900056-S208 |
ROTAPRO Rotational Atherectomy System |
Real-Time Process |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2023-07-17 |
P150005-S076 |
IntellaNav MiFi Open-Irrigated (OI) Ablation Catheter |
Real-Time Process |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2023-07-12 |
P170023-S015 |
Bulkamid Urethral Bulking System |
Real-Time Process |
LNM |
Agent, Bulking, Injectable For Gastro-Urology Use |
Unknown |
| 2023-07-10 |
P150031-S056 |
Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System |
Real-Time Process |
NHL |
— |
— |
| 2023-07-07 |
P960040-S494 |
Implantable Cardioverter Defibrillators (ICDs) |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-07-07 |
P110042-S186 |
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-07-07 |
P010012-S573 |
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2023-07-06 |
P960004-S103 |
FINELINE® II Sterox, FINELINE® II EZ Sterox |
30-Day Notice |
NVN |
— |
— |
| 2023-07-06 |
P910073-S172 |
ENDOTAK RELIANCE®, RELIANCE 4-FRONT |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-07-06 |
P150012-S147 |
INGEVITY MRI, INGEVITY+ |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-07-06 |
P110042-S185 |
EMBLEM S-ICD, |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-07-06 |
P010012-S572 |
ACUITY Spiral, ACUITY X4 Straight, ACUITY X4 Spiral |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2023-06-30 |
P150031-S059 |
Vercise Deep Brain Stimulation (DBS) Systems |
30-Day Notice |
NHL |
— |
— |
| 2023-06-30 |
P030017-S364 |
Precision Spinal Cord Stimulator (SCS) Systems |
30-Day Notice |
LGW |
— |
— |
| 2023-06-29 |
P960004-S102 |
FINELINE®II EZ Sterox Bipolar IS-1 Atrial/Ventricular, J shaped Lead Stylets Limber, J shaped Lead Stylets Firm, J shape |
30-Day Notice |
NVN |
— |
— |
| 2023-06-29 |
P150012-S146 |
INGEVITY MRI Endocardial Steroid-eluting MR Conditional Stylet delivered Pace/Sense Lead, INGEVITY+ Pace/Sense Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-06-28 |
P000053-S131 |
AMS 800 Artificial Urinary Sphincter with InhibiZone |
30-Day Notice |
EZY |
Device, Incontinence, Mechanical/Hydraulic |
Gastroenterology, Urology |
| 2023-06-28 |
N970012-S198 |
AMS 700 Inflatable Penile Prosthesis with InhibiZone |
30-Day Notice |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2023-06-21 |
P190006-S069 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2023-06-21 |
P180046-S069 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2023-06-16 |
P140026-S024 |
ENROUTE® Transcarotid Stent System |
Normal 180 Day Track |
NIM |
— |
— |
| 2023-06-15 |
P110042-S181 |
EMBLEM S-ICD Programmer Software Application, EMBLEM S-ICD Pulse Generator, EMBLEM MRI S-ICD Pulse Generator |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-06-14 |
P980033-S062 |
WALLSTENT Venous Endoprosthesis with Unistep Plus Delivery System |
30-Day Notice |
QKJ |
Stent, Central Venous |
Unknown |
| 2023-06-14 |
P930031-S072 |
WALLSTENT TIPS Endoprosthesis with Unistep Plus Delivery System |
30-Day Notice |
MIR |
Shunt, Portosystemic, Endoprosthesis |
Unknown |
| 2023-06-14 |
P050019-S038 |
Carotid WALLSTENT Monorail Endoprosthesis System |
30-Day Notice |
NIM |
— |
— |
| 2023-06-13 |
P190006-S063 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
QON |
— |
— |
| 2023-06-13 |
P180046-S063 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
EZW |
— |
— |
| 2023-06-12 |
P200036-S006 |
eCoin implanted tibial stimulator |
Real-Time Process |
QPT |
Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence |
Unknown |
| 2023-06-12 |
P150003-S093 |
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail®), SYNERGY SHIELD Everolimus-Eluting Plat |
Real-Time Process |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2023-06-06 |
P030017-S351 |
Precision Passing Elevator |
Normal 180 Day Track |
LGW |
— |
— |
| 2023-06-02 |
P190006-S066 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
QON |
— |
— |
| 2023-06-02 |
P180046-S066 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
EZW |
— |
— |
| 2023-05-17 |
P150012-S145 |
INGEVITY+ and INGEVITY MRI Pace/Sense leads |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-05-17 |
P030017-S360 |
Precision Spinal Cord Stimulator (SCS) Systems |
30-Day Notice |
LGW |
— |
— |
| 2023-05-16 |
P190006-S068 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2023-05-16 |
P180046-S068 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2023-05-15 |
P150031-S058 |
Vercise Deep Brain Stimulation (DBS) Systems |
30-Day Notice |
NHL |
— |
— |
| 2023-05-15 |
P030017-S362 |
Precision Spinal Cord Stimulator (SCS) Systems |
30-Day Notice |
LGW |
— |
— |
| 2023-05-12 |
P150031-S057 |
Vercise Deep Brain Stimulation (DBS) Systems |
30-Day Notice |
NHL |
— |
— |
| 2023-05-12 |
P110042-S182 |
EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) Anneal Parameters |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-05-12 |
P030017-S361 |
Precision Spinal Cord Stimulator (SCS Systems) |
30-Day Notice |
LGW |
— |
— |
| 2023-05-11 |
P960040-S491 |
NG3 Implantable Cardioverter Defibrillators (ICDs), NG4 ICDs |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-05-11 |
P150012-S142 |
Accolade MRI Pacemakers |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-05-11 |
P130013-S052 |
WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System |
Normal 180 Day Track |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2023-05-11 |
P110042-S183 |
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-05-11 |
P010012-S568 |
NG3 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), NG4 CRT-Ds |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2023-05-11 |
N970003-S284 |
Accolade Pacemakers |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-05-10 |
P900056-S207 |
Rotablator and ROTAPRO Rotational Atherectomy Systems |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2023-05-08 |
P150012-S144 |
ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, ACCOLADE MRI EL |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-05-08 |
P090003-S054 |
Express LD Iliac Premounted Stent System |
Real-Time Process |
NIO |
Stent, Iliac |
Unknown |
| 2023-05-08 |
N970003-S286 |
ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR, |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-05-05 |
P950020-S138 |
Wolverine Coronary Cutting Balloon |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2023-05-05 |
P150003-S095 |
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY MEGATRON Everolimus-Eluting Platinum Chromi |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2023-05-01 |
P960040-S492 |
Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-05-01 |
P150012-S143 |
Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-05-01 |
P110042-S184 |
Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-05-01 |
P010012-S569 |
Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2023-05-01 |
N970003-S285 |
Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-04-27 |
P980003-S095 |
Chilli II Cooled RF Ablation System |
30-Day Notice |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2023-04-27 |
P920047-S130 |
Blazer II Cardiac Ablation System |
30-Day Notice |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2023-04-27 |
P900056-S206 |
Rotablator Rotational Angioplasty System Guidewire |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2023-04-27 |
P150005-S075 |
Blazer Open Irrigated Cardiac Ablation System |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2023-04-27 |
P020025-S138 |
Blazer IITM XP Cardiac RF Ablation System (also branded as Blazer II Prime XP, IntellaTip MiFi XP, IntellaTip MiFi OI, I |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2023-04-26 |
P950020-S137 |
WOLVERINE Coronary Cutting Balloon® |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2023-04-21 |
P960040-S490 |
TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-04-21 |
P910077-S191 |
LATITUDE NXT Release 7.3 |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-04-21 |
P150012-S140 |
INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-04-21 |
P110042-S178 |
EMBLEM S-ICD |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-04-21 |
P010012-S567 |
COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT |
Real-Time Process |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2023-04-21 |
N970003-S283 |
ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, INSIGNIA, ALTRUA 2 |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-04-19 |
P900056-S205 |
Rotablatorand ROTAPRO Rotational Atherectomy System |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2023-04-19 |
P170023-S014 |
Bulkamid Urethral Bulking System |
30-Day Notice |
LNM |
Agent, Bulking, Injectable For Gastro-Urology Use |
Unknown |
| 2023-04-19 |
P150012-S139 |
INGEVITY MRI, INGEVITY+ |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-04-18 |
P190019-S020 |
Ranger-Over-The-Wire Paclitaxel Coated Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2023-04-10 |
P190019-S019 |
Ranger Paclitaxel-Coated PTA Balloon Catheter OTW, Ranger Paclitaxel-Coated PTA Balloon Catheter SL |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2023-04-10 |
P180011-S052 |
Eluvia Drug-Eluting Vascular Stent System |
Normal 180 Day Track No User Fee |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2023-04-10 |
P150003-S094 |
Synergy II Everolimus-Eluting Platinum Chromium Coronary Stent System MR, Synergy Megatron Everolimus-Eluting Platinum C |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2023-04-10 |
P110010-S210 |
Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent System MR, Promus Premier Everolimus-Eluting Platinum C |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2023-04-04 |
P190006-S067 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2023-04-04 |
P180046-S067 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2023-03-29 |
P130013-S058 |
WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2023-03-24 |
P190019-S011 |
RangerOver-The-Wire Paclitaxel-Coated PTA Balloon Catheter |
135 Review Track For 30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2023-03-21 |
P180011-S054 |
Eluvia Drug Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2023-03-21 |
P140028-S077 |
Innova Self-Expanding Stent System |
30-Day Notice |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2023-03-21 |
P110035-S069 |
Epic Vascular Self-Expanding Stent System |
30-Day Notice |
NIO |
Stent, Iliac |
Unknown |
| 2023-03-15 |
P150003-S091 |
SYNERGY and SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2023-03-15 |
P110010-S208 |
PROMUS ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2023-03-14 |
P110042-S179 |
Telemetry Wand |
Normal 180 Day Track No User Fee |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-03-13 |
P200036-S005 |
eCoin implanted tibial stimulator |
Real-Time Process |
QPT |
Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence |
Unknown |
| 2023-03-10 |
P950020-S135 |
WOLVERINE Coronary Cutting Balloon® |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2023-03-10 |
P150003-S092 |
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent Systems |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2023-03-10 |
P110010-S209 |
Promus Everolimus-Eluting Platinum Chromium Coronary Stent System |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2023-03-10 |
P050019-S037 |
Carotid WALLSTENT Monorail Endoprosthesis System |
30-Day Notice |
NIM |
— |
— |
| 2023-03-09 |
P950020-S136 |
WOLVERINE Coronary Cutting Balloon® |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2023-03-08 |
P090003-S055 |
Express LD Iliac Premounted Stent System |
30-Day Notice |
NIO |
Stent, Iliac |
Unknown |
| 2023-03-08 |
P060006-S106 |
Express SD Renal Monorail Premounted Stent System |
30-Day Notice |
NIN |
Stent, Renal |
Unknown |
| 2023-03-02 |
P950020-S133 |
Wolverine Coronary Cutting Balloon |
Real-Time Process |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2023-03-02 |
P190019-S018 |
Ranger Paclitaxel-Coated PTA Balloon Catheter |
Real-Time Process |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2023-03-02 |
P190006-S065 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2023-03-02 |
P180046-S065 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2023-03-02 |
P150003-S090 |
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Coro |
Real-Time Process |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2023-03-02 |
P130030-S075 |
REBEL Platinum Chromium Coronary Stent System |
Real-Time Process |
MAF |
Stent, Coronary |
Unknown |
| 2023-03-02 |
P110010-S207 |
Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus Elite Everolimus-Eluting Platinum Chro |
Real-Time Process |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2023-03-02 |
P060006-S105 |
Express SD Renal Monorail Premounted Stent System |
Real-Time Process |
NIN |
Stent, Renal |
Unknown |
| 2023-03-01 |
P150012-S141 |
INGEVITY and INGEVITY+ |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-02-23 |
P150031-S052 |
Vercise Genus DBS System |
Real-Time Process |
NHL |
— |
— |
| 2023-02-23 |
P000053-S129 |
AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone |
30-Day Notice |
EZY |
Device, Incontinence, Mechanical/Hydraulic |
Gastroenterology, Urology |
| 2023-02-21 |
P110042-S180 |
EMBLEM S-ICD, EMBLEM MRI S-ICD, |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-02-16 |
P180011-S053 |
Eluvia Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2023-02-16 |
P140028-S076 |
Innova Self-Expanding Stent System |
30-Day Notice |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2023-02-10 |
N970012-S195 |
AMS 700 Inflatable Penile Prosthesis, AMS 700 Inflatable Penile Prosthesis with InhibiZone |
30-Day Notice |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2023-02-07 |
P190006-S054 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
QON |
— |
— |
| 2023-02-07 |
P180046-S054 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
EZW |
— |
— |
| 2023-02-02 |
P900056-S204 |
Rotablator and ROTAPRO Rotational Atherectomy System |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2023-02-01 |
P190006-S064 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2023-02-01 |
P180046-S064 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2023-02-01 |
P150003-S088 |
Synergy XD Everolimus-Eluting Platinum Chromium Coronary Stent System, Synergy Megatron Everolimus-Eluting Platinum Chro |
Normal 180 Day Track |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2023-02-01 |
P050019-S035 |
Carotid Wallstent Monorail Endoprosthesis |
Real-Time Process |
NIM |
— |
— |
| 2023-01-30 |
P190006-S056 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
QON |
— |
— |
| 2023-01-30 |
P180046-S056 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
EZW |
— |
— |
| 2023-01-20 |
P130013-S056 |
WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System |
Real-Time Process |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2023-01-20 |
P130013-S053 |
WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System |
Real-Time Process |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2023-01-18 |
P950020-S134 |
WOLVERINE Coronary Cutting Balloon® |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2023-01-16 |
P910073-S171 |
RELIANCE 4-FRONT |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-01-06 |
P150031-S054 |
Vercise Deep Brain Stimulation (DBS) Systems |
30-Day Notice |
NHL |
— |
— |
| 2023-01-06 |
P030017-S356 |
Precision Spinal Cord Stimulator (SCS) Systems |
30-Day Notice |
LGW |
— |
— |
| 2023-01-04 |
P030017-S359 |
Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI, Spectra WaveWriter, and WaveWriter Alpha Sp |
30-Day Notice |
LGW |
— |
— |
| 2022-12-20 |
P960040-S489 |
ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM EL ICD DR, VIGILANT EL ICD VR |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-12-20 |
P960040-S483 |
ICD Devices |
Normal 180 Day Track |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-12-20 |
P910077-S188 |
LATITUDE NXT Release 7.1.5 |
Normal 180 Day Track |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-12-20 |
P150012-S138 |
PG ESSENTIO MRI SR, PG ESSENTIO MRI DR, PG PROPONENT MRI SR, PG PROPONENT MRI DR, PG ACCOLADE MRI SR, PG ACCOLADE MRI DR |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-12-20 |
P150012-S131 |
Pacemaker Devices |
Normal 180 Day Track |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-12-20 |
P110042-S173 |
Subcutaneous ICD Devices |
Normal 180 Day Track |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-12-20 |
P010012-S566 |
MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, VIGILANT CRT-D, VIGILANT X4 CRT-D, RESONATE CRT- |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2022-12-20 |
P010012-S559 |
CRT-D Resynchronization Devices |
Normal 180 Day Track |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2022-12-20 |
N970003-S282 |
ESSENTIO SR, ESSENTIO DR, PROPONENT SR, PROPONENT DR, ACCOLADE SR, ACCOLADE DR, ALTRUA 2 SR, ALTRUA 2 DR |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-12-20 |
N970003-S277 |
Pacemaker Devices |
Normal 180 Day Track |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-12-19 |
P190006-S062 |
Axonics Sacral Neuromodulation System (bowel) |
Normal 180 Day Track |
QON |
— |
— |
| 2022-12-19 |
P180046-S062 |
Axonics Sacral Neuromodulation System (Urinary) |
Normal 180 Day Track |
EZW |
— |
— |
| 2022-12-19 |
P030017-S353 |
Wave Writer Alpha Spinal Cord Stimulator (SCS) System, Spectra Wave Writer Spinal Cord Stimulator (SCS) System, Precis |
30-Day Notice |
LGW |
— |
— |
| 2022-12-17 |
P150031-S053 |
Vercise Deep Brain Stimulation (DBS) Systems |
30-Day Notice |
NHL |
— |
— |
| 2022-12-17 |
P030017-S355 |
Precision Spinal Cord Stimulator (SCS) Systems |
30-Day Notice |
LGW |
— |
— |
| 2022-12-16 |
P140026-S026 |
ENROUTE Transcarotid Stent System |
30-Day Notice |
NIM |
— |
— |
| 2022-12-16 |
P140026-S025 |
ENROUTE® Transcarotid Stent System |
30-Day Notice |
NIM |
— |
— |
| 2022-12-15 |
P150012-S137 |
INGEVITY+ and INGEVITY MRI |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-12-14 |
P960040-S488 |
INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI ICD DR, MOMENTUM EL ICD VR, MOMENTUM EL |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-12-14 |
P910077-S190 |
LATITUDE Wave Communicator Model 6290 |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-12-14 |
P150012-S136 |
ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, ACCOLADE MRI EL |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-12-14 |
P110042-S177 |
SICD Gen 2, SICD MRI |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-12-14 |
P010012-S565 |
MOMENTUM CRT-D, MOMENTUM, MOMENTUM X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, DYNAGEN CRT-D, DYNAGEN X4 CRT-D, VIGIL |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2022-12-14 |
N970003-S281 |
ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR, |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-12-12 |
P960040-S484 |
Implantable Cardioverter Defibrillator (ICD) |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-12-12 |
P150012-S134 |
Accolade Family of Devices Pacemakers, and Cardiac Resynchronization Therapy Pacemakers (CRT-Ps) |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-12-12 |
P150012-S132 |
MRI Pacemakers |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-12-12 |
P110042-S174 |
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-12-12 |
P010012-S560 |
Cardiac Resynchronization Therapy Defibrillator (CRT-D) |
Real-Time Process |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2022-12-12 |
N970003-S280 |
Accolade Family of Devices Pacemakers, and Cardiac Resynchronization Therapy Pacemakers (CRT-Ps) |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-12-12 |
N970003-S278 |
Non-MRI Pacemakers |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-12-07 |
P980037-S089 |
AngioJet Spiroflex Thrombectomy Set, AngioJet Spiroflex VG Thrombectomy Set |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2022-12-07 |
P950020-S132 |
WOLVERINE Coronary Cutting Balloon® |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2022-12-07 |
P110042-S176 |
EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-12-02 |
P200029-S004 |
TheraSphere |
Normal 180 Day Track No User Fee |
NAW |
Microspheres Radionuclide |
Unknown |
| 2022-11-30 |
P200036-S004 |
eCoin Implant Tibial Stimulator |
Normal 180 Day Track No User Fee |
QPT |
Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence |
Unknown |
| 2022-11-28 |
P980033-S061 |
WALLSTENT Venous Endoprosthesis with Unistep Plus Delivery System |
30-Day Notice |
QKJ |
Stent, Central Venous |
Unknown |
| 2022-11-28 |
P950020-S130 |
WOLVERINE Coronary Cutting Balloon® |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2022-11-28 |
P930031-S071 |
WALLSTENT TIPS Endoprosthesis with Unistep Plus Delivery System |
30-Day Notice |
MIR |
Shunt, Portosystemic, Endoprosthesis |
Unknown |
| 2022-11-28 |
P150003-S089 |
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent Systems |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2022-11-28 |
P110010-S206 |
Promus Everolimus-Eluting Platinum Chromium Coronary Stent Systems |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2022-11-28 |
P090003-S053 |
Express® LD Iliac Premounted Stent System |
30-Day Notice |
NIO |
Stent, Iliac |
Unknown |
| 2022-11-28 |
P050019-S036 |
Carotid WALLSTENT Monorail Endoprosthesis System |
30-Day Notice |
NIM |
— |
— |
| 2022-11-23 |
P190019-S017 |
Ranger-Over-The-Wire Paclitaxel Coated Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2022-11-22 |
P930031-S070 |
Wallstent TIPS Endoprosthesis with Unistep Plus Delivery System |
30-Day Notice |
MIR |
Shunt, Portosystemic, Endoprosthesis |
Unknown |
| 2022-11-22 |
P150031-S051 |
Vercise Deep Brain Stimulation (DBS) Systems |
30-Day Notice |
NHL |
— |
— |
| 2022-11-22 |
P030017-S352 |
Precision Spinal Cord Stimulator (SCS) Systems |
30-Day Notice |
LGW |
— |
— |
| 2022-11-21 |
P150005-S072 |
Open-Irrigated Cardiac Ablation Catheters |
Real-Time Process |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2022-11-17 |
P950020-S131 |
WOLVERINE Coronary Cutting Balloon |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2022-11-15 |
P980003-S094 |
Chilli Cooled RF Ablation System |
30-Day Notice |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2022-11-15 |
P960040-S482 |
Bi-Directional Torque Wrench Model 6628 |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-11-15 |
P950020-S128 |
WLOVERINE Coronary Cutting Balloon |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2022-11-15 |
P920047-S129 |
Blazer II Cardiac Ablation System and Cable |
30-Day Notice |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2022-11-15 |
P900056-S203 |
Rotablator Rotational Atherectomy System |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2022-11-15 |
P190019-S016 |
Ranger Paclitaxel-Coated PTA Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2022-11-15 |
P150005-S073 |
Blazer Open-Irrigated Ablation Catheter |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2022-11-15 |
P130030-S074 |
REBEL Platinum Chromium Coronary Stent System Monorail and Over the Wire |
30-Day Notice |
MAF |
Stent, Coronary |
Unknown |
| 2022-11-15 |
P110010-S205 |
PROMUS Element Plus and Promus PREMIER and Promus ELITE Everolimus-Eluting Stent System |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2022-11-15 |
P060006-S104 |
Express® SD Renal Monorail Premounted Stent System |
30-Day Notice |
NIN |
Stent, Renal |
Unknown |
| 2022-11-15 |
P020025-S137 |
Blazer II XP Cardiac Ablation Catheter and Cable |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2022-11-15 |
P010012-S558 |
Bi-Directional Torque Wrench Model 6628 |
Real-Time Process |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2022-11-14 |
P000053-S128 |
AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone |
30-Day Notice |
EZY |
Device, Incontinence, Mechanical/Hydraulic |
Gastroenterology, Urology |
| 2022-11-14 |
N970012-S194 |
AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone |
30-Day Notice |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2022-11-10 |
P190019-S015 |
Ranger-Over-The-Wire Paclitaxel Coated Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2022-11-09 |
N970012-S193 |
AMS 700 Inflatable Penile Prosthesis, AMS 700 Inflatable Penile Prosthesis with InhibiZone |
30-Day Notice |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2022-11-08 |
P150012-S129 |
ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-11-08 |
N970003-S275 |
ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-11-07 |
P950020-S129 |
WOLVERINE Coronary Cutting Balloon® |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2022-11-07 |
P180011-S051 |
ELUVIA Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2022-11-07 |
P140028-S075 |
INNOVA Vascular Self-Expanding Stent System |
30-Day Notice |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2022-11-07 |
P130013-S055 |
WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2022-11-07 |
P110035-S068 |
EPIC Vascular Self-Expanding Stent System |
30-Day Notice |
NIO |
Stent, Iliac |
Unknown |
| 2022-11-02 |
P960006-S055 |
Sweet TIP® RX Steroid Eluting Lead |
30-Day Notice |
NVN |
— |
— |
| 2022-11-02 |
P960004-S101 |
Thinline Endocardial Pacing Leads |
30-Day Notice |
NVN |
— |
— |
| 2022-11-02 |
P930035-S033 |
Ventak® P2 System |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-11-02 |
P910077-S189 |
Ventak® PRX Pulse Generator |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-11-02 |
P910073-S170 |
Endotak Lead System |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-11-02 |
P830060-S088 |
Ventak and Automatic Implantable Cardioverter Defibrillator (AICD) Systems |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-11-02 |
P150012-S135 |
Imagerade MR Conditional Pacing System and Ingevity Pacing/Sense Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-11-02 |
P010012-S564 |
Contak CD, Easytrak, Livian, Cognis and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibrill |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2022-11-01 |
P190006-S061 |
Axonics Sacral Neuromodulation System (Bowel) |
Normal 180 Day Track |
QON |
— |
— |
| 2022-11-01 |
P180046-S061 |
Axonics Sacral Neuromodulation System (Urinary) |
Normal 180 Day Track |
EZW |
— |
— |
| 2022-10-28 |
P960040-S486 |
ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-10-28 |
P150012-S133 |
PG ESSENTIO MRI SR, PG ESSENTIO MRI DR, PG PROPONENT MRI SR, PG PROPONENT MRI DR, PG ACCOLADE MRI SR, PG ACCOLADE MRI DR |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-10-28 |
P130013-S054 |
WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System |
Normal 180 Day Track No User Fee |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2022-10-28 |
P110042-S175 |
S-ICD GEN 2, S-ICD EMBLEM MRI |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-10-28 |
P010012-S562 |
ICD ORIGEN CRT-D, MOMENTUM CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, ICD AUTOGEN CRT-D, VIGILANT CRT-D, VIGILANT X4 CR |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2022-10-28 |
N970003-S279 |
PG ESSENTIO SR SL WW, PG ESSENTIO DR SL WW, PG ESSENTIO DR EL WW, PG PROPONENT SR SL US, PG PROPONENT DR SL US, PG PROPO |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-10-27 |
P150031-S049 |
Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System |
Normal 180 Day Track |
NHL |
— |
— |
| 2022-10-26 |
P170023-S013 |
Bulkamid Urethral Bulking System |
30-Day Notice |
LNM |
Agent, Bulking, Injectable For Gastro-Urology Use |
Unknown |
| 2022-10-26 |
P170023-S012 |
Bulkamid Urethral Bulking System |
30-Day Notice |
LNM |
Agent, Bulking, Injectable For Gastro-Urology Use |
Unknown |
| 2022-10-17 |
P950020-S127 |
WOLVERINE Coronary Cutting Balloon® |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2022-10-17 |
P900056-S202 |
ROTAWIRE Guidewire |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2022-10-17 |
P130013-S050 |
WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System, WATCHMAN Left Atrial Appendage (LAA) Closure Te |
Real-Time Process |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2022-10-14 |
P980033-S060 |
Venous Wallstent and Wallstent Venous Endoprosthesis with Unistep Plus Delivery System |
30-Day Notice |
QKJ |
Stent, Central Venous |
Unknown |
| 2022-10-14 |
P960040-S487 |
ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-10-14 |
P910073-S169 |
REALIANCE 4-SITE Family of Defibrillation Leads |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-10-14 |
P110010-S195 |
Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System and Promus Elite Everolimus-Eluting Platinum C |
135 Review Track For 30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2022-10-14 |
P010012-S563 |
ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, VIGILANT CRT-D, VIGILANT X4 CR |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2022-10-12 |
P190019-S014 |
Ranger Paclitaxel-Coated PTA Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2022-10-05 |
P140008-S024 |
ORBERA ® Intragastric Balloon (IGB) System |
Real-Time Process |
LTI |
Implant, Intragastric For Morbid Obesity |
Unknown |
| 2022-09-30 |
P950020-S126 |
WOLVERINE Coronary Cutting Balloon® |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2022-09-27 |
P960040-S481 |
ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-09-27 |
P150012-S130 |
ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT MRI SR, PROPONENT MRI DR, PROPONENT MRI EL DR, ACCOLAD |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-09-27 |
P110042-S172 |
EMBLEM S-ICD, EMBLEM MRI S ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-09-27 |
P010012-S557 |
ORIGEN CRT-D, ORIGEN X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, DYNAGEN CRT-D, DYNAGEN X4 CRT-D, AUTOGEN CRT-D, MOMENTUM C |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2022-09-27 |
N970003-S276 |
ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR, ACCO |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-09-21 |
P920047-S128 |
INTELLANAV ST Ablation Catheter, BLAZER II Temperature Ablation Catheter, BLAZER II HTD Temperature Ablation Cathete |
30-Day Notice |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2022-09-21 |
P150005-S071 |
BLAZER OPEN-IRRIGATED Ablation Catheter, INTELANAV OPEN-IRRIGATED Ablation Catheter, INTELLANAV MIFI OPEN-IRRIGATED A |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2022-09-21 |
P020025-S136 |
BLAZER II XP Temperature Ablation Catheter, BLAZER PRIME XP Temperature Ablation Catheter, INTELLATIP MIFI XP Tempe |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2022-09-15 |
P950020-S125 |
WOLVERINE Coronary Cutting Balloon® |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2022-09-08 |
P190006-S059 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2022-09-08 |
P180046-S059 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2022-09-07 |
P190006-S060 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2022-09-07 |
P180046-S060 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2022-09-02 |
P900056-S200 |
Rotablatorand ROTAPRO Rotational Atherectomy System |
135 Review Track For 30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2022-09-02 |
P130013-S043 |
WATCHMAN and WATCHMAN FLX Left Atrial Appendage Closure Devices with Delivery Systems |
Normal 180 Day Track |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2022-09-01 |
P110010-S204 |
Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus Elite Everolimus-Eluting Platinum Chro |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2022-09-01 |
P000053-S127 |
AMS 800 Artificial Urinary Sphincter (AUS) with and without lnhibiZone Treatment |
30-Day Notice |
EZY |
Device, Incontinence, Mechanical/Hydraulic |
Gastroenterology, Urology |
| 2022-09-01 |
N970012-S192 |
AMS 700 Inflatable Penile Prosthesis (IPP) with and without lnhibiZone Treatment |
30-Day Notice |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2022-08-29 |
P180011-S050 |
ELUVIA Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2022-08-29 |
P150012-S125 |
INGEVITY+ Active Fixation Pace/Sense Lead |
Normal 180 Day Track No User Fee |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-08-29 |
P140028-S074 |
Innova Vascular Self-Expanding Stent System |
30-Day Notice |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2022-08-26 |
P960040-S476 |
RESONATE HF, RESONATE EL, MOMENTUM EL, VIGILIANT EL, PERCIVA HF, PERCIVA |
Normal 180 Day Track No User Fee |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-08-26 |
P010012-S552 |
RESONATE HF, RESONATE, RESONATE X4, MOMENTUM, MOMENTUM X4, VIGILIANT, VIGILIANT X4 |
Normal 180 Day Track No User Fee |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2022-08-25 |
P090003-S052 |
Express® LD Iliac Premounted Stent System |
30-Day Notice |
NIO |
Stent, Iliac |
Unknown |
| 2022-08-19 |
P140026-S023 |
ENROUTE Transcarotid Stent System |
Normal 180 Day Track No User Fee |
NIM |
— |
— |
| 2022-08-18 |
P110010-S201 |
PROMUS PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, PROMUS ELITE Everolimus-Eluting Platinum Chro |
135 Review Track For 30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2022-08-17 |
P200036-S001 |
eCoin Peripheral Neurostimulator |
Normal 180 Day Track No User Fee |
QPT |
Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence |
Unknown |
| 2022-08-05 |
P170023-S011 |
Bulkamid Urethral Bulking System |
30-Day Notice |
LNM |
Agent, Bulking, Injectable For Gastro-Urology Use |
Unknown |
| 2022-08-05 |
P170023-S010 |
Bulkamid Urethral Bulking System |
30-Day Notice |
LNM |
Agent, Bulking, Injectable For Gastro-Urology Use |
Unknown |
| 2022-08-05 |
P170023-S009 |
Bulkamid Urethral Bulking System |
30-Day Notice |
LNM |
Agent, Bulking, Injectable For Gastro-Urology Use |
Unknown |
| 2022-07-29 |
P130013-S051 |
WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2022-07-28 |
P960004-S100 |
Fineline II Sterox, Sterox EZ pace / sense leads |
30-Day Notice |
NVN |
— |
— |
| 2022-07-27 |
P150012-S127 |
PG Essentio MRI SR SL, PG Essentio MRI DR SL, PG Essentio MRI DR EL, PG Proponent MRI SR SL, PG Proponent MRI DR EL, PG |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-07-27 |
N970003-S274 |
PG Essentio SR SL, PG Essentio DR SL, PG Essentio DR EL, PG Proponent SR SL, PG Proponent DR SL, PD Proponent DR EL, PG |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-07-25 |
P150012-S128 |
Ingevity MRI pace/sense lead, Ingevity+ MRI pace/sense lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-07-22 |
P960040-S480 |
ICD Inogen VR, ICD Dynagen VR, ICD Dynagen DR, Momentum EL ICD VR, Momentum EL ICD DR, Vigilant EL ICD VR, Vigilant EL I |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-07-22 |
P010012-S556 |
Momentum CRT-D, Momentum X4 CRT-D, ICD Inogen CRT-D, ICD Dynagen CRT-D, Vigilant CRT-D, Vigilant X4 CRT-D, Resonate CRT- |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2022-07-20 |
P190006-S057 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2022-07-20 |
P180046-S057 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2022-07-20 |
P140026-S020 |
ENROUTE Transcarotid Stent System |
Normal 180 Day Track No User Fee |
NIM |
— |
— |
| 2022-07-18 |
P950020-S124 |
WOLVERINE Coronary Cutting Balloon® |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2022-07-15 |
P200036-S003 |
eCoin (Electroceutical Coin) |
Normal 180 Day Track No User Fee |
QPT |
Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence |
Unknown |
| 2022-07-13 |
P960040-S479 |
ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, ICD ORIGEN VR, ICD ORIGEN DR |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-07-13 |
P950020-S123 |
WOLVERINE Coronary Cutting Balloon® |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2022-07-13 |
P150012-S126 |
PG ESSENTIO MRI SR, PG ESSENTIO MRI DR, PG PROPONENT MRI SR, PG PROPONENT MRI DR, PG ACCOLADE MRI SR, PG ACCOLADE MRI DR |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-07-13 |
P110042-S171 |
SICD Gen 2 A209, SICD MRI A219 |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-07-13 |
P010012-S555 |
ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, VIGILANT CRT-D, VIGILANT X4 CR |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2022-07-13 |
N970003-S273 |
PG ESSENTIO SR, PG ESSENTIO DR, PG PROPONENT SR, PG PROPONENT DR, PG ACCOLADE SR, PG ACCOLADE DR, PG ALTRUA 2 SR, PG ALT |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-07-06 |
P000053-S126 |
AMS 800 Artificial Urinary Sphincter, AMS 800 Artificial Urinary Sphincter with InhibiZone Treatment |
30-Day Notice |
EZY |
Device, Incontinence, Mechanical/Hydraulic |
Gastroenterology, Urology |
| 2022-07-01 |
P130013-S049 |
WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2022-06-28 |
P980033-S059 |
Wallstent Venous Endoprosthesis with Unistep Plus Delivery System |
30-Day Notice |
QKJ |
Stent, Central Venous |
Unknown |
| 2022-06-28 |
P930031-S069 |
Wallstent TIPS Endoprosthesis with Unistep Plus Delivery System |
30-Day Notice |
MIR |
Shunt, Portosystemic, Endoprosthesis |
Unknown |
| 2022-06-24 |
P140026-S021 |
ENROUTE® Transcarotid Stent System |
30-Day Notice |
NIM |
— |
— |
| 2022-06-23 |
P150031-S050 |
Vercise Genus R32, Vercise Genus R16 |
30-Day Notice |
NHL |
— |
— |
| 2022-06-23 |
P030017-S350 |
WaveWriter Alpha, WaveWriter Alpha 16 |
30-Day Notice |
LGW |
— |
— |
| 2022-06-21 |
P960040-S478 |
ICD INOGEN VR DF4, ICD INOGEN VR DF1/IS1, ICD INOGEN DR DF4/IS1, ICD INOGEN DR DF1/IS1, ICD DYNAGEN VR DF1/IS1, ICD DYNA |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-06-21 |
P110042-S170 |
Emblem S-ICD, Emblem MRI S-ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-06-21 |
P010012-S554 |
ICD INOGEN CRT-D DF4/IS1, ICD INOGEN CRT-D DF/IS1/IS1, ICD INOGEN CRT-D DF1/IS1/IS4, ICD INOGEN CRT-D DF4/IS1/IS4, ICD D |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2022-05-25 |
P150003-S086 |
SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY MEGATRON Everolimus-Eluting Platinum Chro |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2022-05-19 |
P950020-S121 |
WOLVERINE Coronary Cutting Balloon |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2022-05-19 |
P150003-S087 |
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Cono |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2022-05-19 |
P130013-S048 |
WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2022-05-18 |
P110042-S169 |
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) |
Normal 180 Day Track No User Fee |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-05-13 |
P190006-S055 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2022-05-13 |
P180046-S055 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2022-05-06 |
P980037-S088 |
AngioJet Rheolythic Thrombectomy Catheter System |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2022-05-06 |
P180011-S049 |
ELUVIA Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2022-05-06 |
P150003-S085 |
SYNERGY Drug Eluting Coronary Stent System |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2022-05-06 |
P140028-S073 |
lnnova Vascular Self-Expanding Stent with Delivery System |
30-Day Notice |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2022-05-06 |
P130013-S047 |
WATCHMAN FLX Left Atrial Appendage Closure System |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2022-05-06 |
P110035-S067 |
Epic Vascular Self-Expanding Stent System |
30-Day Notice |
NIO |
Stent, Iliac |
Unknown |
| 2022-05-03 |
P950020-S122 |
WOLVERINE Coronary Cutting Balloon |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2022-05-03 |
P140026-S019 |
ENROUTE Transcarotid Stent System |
30-Day Notice |
NIM |
— |
— |
| 2022-04-29 |
P110010-S194 |
Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus ELITE Everolimus-Eluting Platinum Chro |
135 Review Track For 30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2022-04-28 |
P900056-S199 |
Rotablator Rotational Angioplasty System, ROTAPRO Rotational Artherectomy System, ROTAWIRE Drive |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2022-04-28 |
P140026-S016 |
ENROUTE Transcarotid Stent System |
Panel Track |
NIM |
— |
— |
| 2022-04-20 |
P190006-S052 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2022-04-20 |
P180046-S052 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2022-04-20 |
P000053-S125 |
AMS 800 Artificial Urinary Sphincter, AMS 800 Artificial Urinary Sphincter with InhibiZone |
30-Day Notice |
EZY |
Device, Incontinence, Mechanical/Hydraulic |
Gastroenterology, Urology |
| 2022-04-20 |
N970012-S191 |
AMS 700 Inflatable Penile Prosthesis, AMS 700 Inflatable Penile Prosthesis with InhibiZone |
30-Day Notice |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2022-04-13 |
P960040-S477 |
Tachy DF4 header core |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-04-13 |
P010012-S553 |
Tachy DF4 header core |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2022-04-04 |
P150031-S048 |
Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System |
Real-Time Process |
NHL |
— |
— |
| 2022-04-01 |
P000053-S124 |
AMS 800 Artificial Urinary Sphincter, AMS 800 Artificial Urinary Sphincter with InhibiZone |
30-Day Notice |
EZY |
Device, Incontinence, Mechanical/Hydraulic |
Gastroenterology, Urology |
| 2022-04-01 |
N970012-S190 |
AMS 700 Inflatable Penile Prosthesis, AMS 700 Inflatable Penile Prosthesis with InhibiZone |
30-Day Notice |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2022-03-31 |
P950020-S118 |
WOLVERINE Coronary Cutting Balloon |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2022-03-30 |
P950020-S120 |
Wolverine Coronary Cutting Balloon |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2022-03-30 |
P900056-S198 |
ROTAPRO Rotational Atherectomy System |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2022-03-30 |
P150003-S084 |
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Coro |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2022-03-30 |
P110010-S203 |
Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus ELITE Everolimus-Eluting Platinum Chro |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2022-03-29 |
P150012-S124 |
LD BG1 TN STR MRI IS1, LD BG1 TN J MRI IS1, LD BG1 PFRET STR MRI IS1, LD INGEVITY PLUS AF IS1 |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-03-24 |
P150031-S045 |
Vercise Genus DBS System |
Normal 180 Day Track |
NHL |
— |
— |
| 2022-03-24 |
P050019-S034 |
Carotid WALLSTENT Monorail Endoprosthesis |
30-Day Notice |
NIM |
— |
— |
| 2022-03-09 |
P950020-S117 |
WOLVERINE Coronary Cutting Balloon® |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2022-03-08 |
P960004-S099 |
FINELINE II pace/sense lead |
30-Day Notice |
NVN |
— |
— |
| 2022-03-08 |
P910073-S168 |
RELIANCE 4-FRONT defibrillation pace/sense lead, ENDOTAK RELIANCE defibrillation pace/sense lead |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-03-08 |
P150012-S123 |
INGEVITY MRI pace/sense lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-03-08 |
P010012-S551 |
ACUITY Spiral Coronary Venous Pace/Sense Lead, ACUITY X4 Coronary Venous Pace/Sense Lead |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2022-03-07 |
P190006-S038 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
QON |
— |
— |
| 2022-03-07 |
P180046-S038 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
EZW |
— |
— |
| 2022-03-07 |
P000053-S123 |
AMS 800 Artificial Urinary Sphincter with InhibiZone |
30-Day Notice |
EZY |
Device, Incontinence, Mechanical/Hydraulic |
Gastroenterology, Urology |
| 2022-03-04 |
P960040-S475 |
Ventak AV Acid VENTAK Prizm DR/VR, Vitality, Cofient, and Teligen Automatic Implantable Cardioveter Defibrillator System |
Normal 180 Day Track No User Fee |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-03-04 |
P010012-S550 |
Contak CD, Easytrak, Livian, Cognis and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibrill |
Normal 180 Day Track No User Fee |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2022-03-03 |
P190006-S051 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2022-03-03 |
P190006-S046 |
Axonics Sacral Neuromodulation System |
Real-Time Process |
QON |
— |
— |
| 2022-03-03 |
P180046-S051 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2022-03-03 |
P180046-S046 |
Axonics Sacral Neuromodulation System |
Real-Time Process |
EZW |
— |
— |
| 2022-03-01 |
P200036 |
eCoin Peripheral Neurostimulator |
Original |
QPT |
Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence |
Unknown |
| 2022-02-25 |
P980003-S093 |
Chilli II Cooled Catheter, Sterile Cables, Tubing Kit |
30-Day Notice |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2022-02-25 |
P950020-S116 |
WOLVERINE Coronary Cutting Balloon |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2022-02-25 |
P920047-S127 |
Blazer II Catheter, Blazer II HTD Catheter, Blazer Prime HTD Catheter, and IntellaNav ST Catheter, Sterile Cables |
30-Day Notice |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2022-02-25 |
P900056-S197 |
Rotablator Rotational Angioplasty System Guidewire |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2022-02-25 |
P190019-S013 |
Ranger Paclitaxel-Coated PTA Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2022-02-25 |
P150005-S070 |
Blazer Open Irrigated Catheter, IntellNav MiFi OI Catheter, IntellaNav OI Catheter, and IntellaTip MiFi OI Catheter, Ste |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2022-02-25 |
P130030-S073 |
REBEL Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) |
30-Day Notice |
MAF |
Stent, Coronary |
Unknown |
| 2022-02-25 |
P110010-S202 |
Promus PREMIER and ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2022-02-25 |
P060006-S103 |
Express SD Monorail Premounted Stent System |
30-Day Notice |
NIN |
Stent, Renal |
Unknown |
| 2022-02-25 |
P020025-S135 |
Blazer II XP Catheter, Blazer Prime XP Catheter, IntellaTip MiFi XP Catheter, IntellaNav XP Catheter and IntellaNav MiFi |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2022-02-24 |
P960040-S473 |
ICD Devices |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-02-24 |
P910077-S187 |
Model 3300 LATITUDE Programming System |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-02-24 |
P150012-S120 |
Pacemaker Devices |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-02-24 |
P110042-S167 |
Subcutaneous ICD Devices |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-02-24 |
P010012-S548 |
CRT-D Resynchronization Devices |
Real-Time Process |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2022-02-24 |
N970003-S270 |
Pacemaker Devices |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-02-22 |
P920047-S126 |
IntellaNav ST Ablation Catheter, Blazer II Temperature Ablation Catheter, Blazer II HTD Temperature Ablation Catheter |
30-Day Notice |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2022-02-22 |
P190019-S012 |
Ranger Over-The-Wire Paclitaxel-Coated Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2022-02-22 |
P150005-S069 |
Blazer Open-Irrigated Ablation Catheter, IntellaNav Open-Irrigated Ablation Catheter, IntellaNav MiFi Open-Irrigated |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2022-02-22 |
P020025-S134 |
Blazer II XP Temperature Ablation Catheter, Blazer Prime XP Temperature Ablation Catheter, IntellaTip MiFi XP Tempera |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2022-02-18 |
P080032-S019 |
Alair Bronchial Thermoplasty System |
Normal 180 Day Track No User Fee |
OOY |
Bronchial Thermoplasty System |
Unknown |
| 2022-02-10 |
P190006-S050 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2022-02-10 |
P180046-S050 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2022-02-10 |
P150003-S083 |
SYNERGY, SYNERGY XD and SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2022-02-10 |
P110010-S200 |
Promus Premier and Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent System |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2022-02-09 |
P980037-S087 |
AngioJet Thrombectomy System |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2022-02-01 |
P190006-S044 |
Axonics Sacral Neuromodulation System |
Real-Time Process |
QON |
— |
— |
| 2022-02-01 |
P180046-S044 |
Axonics Sacral Neuromodulation System |
Real-Time Process |
EZW |
— |
— |
| 2022-01-25 |
P900056-S196 |
Rotablator/ROTAPRO Rotational Atherectomy System |
Real-Time Process |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2022-01-25 |
P190006-S049 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2022-01-25 |
P180046-S049 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2022-01-18 |
P190019-S010 |
Ranger Paclitaxel-Coated PTA Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2022-01-14 |
P190006-S047 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2022-01-14 |
P180046-S047 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2022-01-04 |
P190006-S041 |
Axonics Sacral Neuromodulation System |
Real-Time Process |
QON |
— |
— |
| 2022-01-04 |
P180046-S041 |
Axonics Sacral Neuromodulation System |
Real-Time Process |
EZW |
— |
— |
| 2021-12-29 |
P110042-S166 |
Subcutaneous Implantable Cardiac Defibrillators, Emblem MRI S-ICD, Emblem S-ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-12-28 |
P190006-S045 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2021-12-28 |
P180046-S045 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2021-12-23 |
P910073-S165 |
RELIANCE 4-FRONT |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-12-23 |
P180011-S046 |
Eluvia Drug-Eluting Vascular Stent System |
Normal 180 Day Track |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2021-12-23 |
P150012-S121 |
L110 ESSENTIO MRI SR, L111 ESSENTIO MRI DR, L131 ESSENTIO MRI EL DR, L210 PROPONENT, L211 PROPONENT, L231 PROPONENT, |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-12-23 |
P140028-S070 |
Innova Vascular Self-Expanding Stent System |
Normal 180 Day Track |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2021-12-23 |
N970003-S271 |
L100 ESSENTIO SR, L101 ESSENTIO DR, L121 ESSENTIO EL DR, L200 PROPONENT SR, L201 PROPONENT DR, L221 PROPONENT EL D |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-12-21 |
P960040-S474 |
ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-12-21 |
P150012-S122 |
ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, ACCOLADE MRI EL |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-12-21 |
P140008-S023 |
ORBERA® Intragastric Balloon (IGB) System |
30-Day Notice |
LTI |
Implant, Intragastric For Morbid Obesity |
Unknown |
| 2021-12-21 |
P110042-S168 |
SICD Gen 2, SICD MRI |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-12-21 |
P010012-S549 |
ORIGEN CRT-D, ORIGEN X4 CRT-D, MOMENTUM CRT-D, MOMENTUM, MOMENTUM X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, DYNAGEN |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2021-12-21 |
N970003-S272 |
ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-12-17 |
P150003-S081 |
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Cor |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2021-12-17 |
P110042-S164 |
EMBLEM subcutaneous implantable cardioverter defibrillation (S-ICD) Programmer, EMBLEM Pulse Generator (PG) |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-12-16 |
P150003-S080 |
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2021-12-15 |
P180011-S048 |
Eluvia Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2021-12-15 |
P140028-S072 |
Innova Vascular Self-Expanding Stent System |
30-Day Notice |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2021-12-14 |
P150031-S047 |
Vercise Deep Brain Stimulation (DBS) Systems |
30-Day Notice |
NHL |
— |
— |
| 2021-12-14 |
P030017-S349 |
Precision Spinal Cord Stimulator {SCS) Systems |
30-Day Notice |
LGW |
— |
— |
| 2021-12-10 |
P150005-S068 |
IntellaTip MiFi OI, IntellaNav MiFi OI, IntellaNav OI, Blazer OI |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2021-12-10 |
P050019-S033 |
Carotid Wallstent Monorail Endoprosthesis |
30-Day Notice |
NIM |
— |
— |
| 2021-12-06 |
P950020-S115 |
WOLVERINE Coronary Cutting Balloon® |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2021-12-06 |
P950020-S114 |
WOLVERINE Coronary Cutting Balloon® |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2021-11-30 |
P960040-S468 |
TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-11-30 |
P910077-S186 |
LATITUDE Programming System |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-11-30 |
P150012-S116 |
INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-11-30 |
P110042-S159 |
Subcutaneous ICD Devices |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-11-30 |
P010012-S543 |
COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT |
Real-Time Process |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2021-11-30 |
N970003-S267 |
ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, ALTRUA, INSIGNIA I, NEXUS I |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-11-26 |
P900056-S195 |
Rotablator Rotational Angioplasty System, ROTAPRO Rotational Atherectomy System |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2021-11-26 |
P080032-S020 |
Alair Bronchial Thermoplasty System |
30-Day Notice |
OOY |
Bronchial Thermoplasty System |
Unknown |
| 2021-11-22 |
P190006-S043 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2021-11-22 |
P180046-S043 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2021-11-16 |
P110042-S161 |
EMBLEM S-ICD pulse generator (PG) Models A209/A219 |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-11-15 |
P190006-S042 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2021-11-15 |
P180046-S042 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2021-11-15 |
P150031-S039 |
Vercise, Vercise PC, Vercise Gevia, Vercise Genus Deep Brain Stimulation Systems |
135 Review Track For 30-Day Notice |
NHL |
— |
— |
| 2021-11-15 |
P050019-S032 |
Carotid Wallstent Monorail Endoprosthesis |
30-Day Notice |
NIM |
— |
— |
| 2021-11-10 |
P150031-S046 |
Vercise Genus Deep Brain Stimulation (DBS) System |
30-Day Notice |
NHL |
— |
— |
| 2021-11-10 |
P030017-S348 |
WaveWriter Alpha Spinal Cord Stimulator (SCS) System |
30-Day Notice |
LGW |
— |
— |
| 2021-11-03 |
P190006-S036 |
Axonics Sacral Neuromodulation (SNM) System for Bowel Control |
135 Review Track For 30-Day Notice |
QON |
— |
— |
| 2021-11-03 |
P180046-S036 |
Axonics Sacral Neuromodulation (SNM) System for Urinary Control |
135 Review Track For 30-Day Notice |
EZW |
— |
— |
| 2021-11-02 |
P950020-S112 |
Wolverine Coronary Cutting Balloon |
Normal 180 Day Track |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2021-10-21 |
P960040-S472 |
ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR,DYNAGEN MINI ICD D |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-10-21 |
P150012-S119 |
ESSENTIO MRI SR; ESSENTIO MRI DR; ESSENTIO MRI EL DR; PROPONENT MRI SR ; PROPONENT MRI DR; PROPONENT MRI EL DR; ACCOLA |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-10-21 |
P110042-S165 |
EMBLEM S-ICD; EMBLEM MRI S ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-10-21 |
P010012-S547 |
ORIGEN CRT-D; ORIGEN X4 CRT-D; INOGEN CRT-D; INOGEN X4 CRT-D; DYNAGEN CRT-D; DYNAGEN X4 CRT-D; AUTOGEN CRT-D; MOMENTUM C |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2021-10-21 |
N970003-S269 |
ESSENTIO SR; ESSENTIO DR; ESSENTIO EL DR; PROPONENT SR; PROPONENT DR; PROPONENT EL DR; ACCOLADE SR; ACCOLADE DR; ACC |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-10-20 |
P150031-S040 |
Vercise PC, Vercise Gevia and Vercise Genus DBS Systems |
Panel Track |
PJS |
— |
— |
| 2021-10-19 |
P110042-S160 |
EMBLEM S-ICD PG models A209 and A219. |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-10-07 |
P960040-S466 |
Resonate family of CRT-D's |
Normal 180 Day Track No User Fee |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-10-07 |
P960040-S459 |
Resonate, Momentum, Vigilant, Perciva, Autogen, Dynagen, Inogen, Origen Implantable Cardioverter Defibrillators |
Normal 180 Day Track |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-10-07 |
P180011-S047 |
Eluvia Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2021-10-07 |
P150031-S044 |
Vercise Genus Deep Brain Stimulation (DBS) System |
30-Day Notice |
NHL |
— |
— |
| 2021-10-07 |
P140028-S071 |
Innova Self-Expanding Stent System |
30-Day Notice |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2021-10-07 |
P030017-S347 |
Wave Writer Alpha TM Spinal Cord Stimulator (SCS) System |
30-Day Notice |
LGW |
— |
— |
| 2021-10-07 |
P010012-S540 |
Resonate family of CRT-D's |
Normal 180 Day Track No User Fee |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2021-10-07 |
P010012-S528 |
Resonate, Momentum, Vigilant, Autogen, Dynagen, Inogen, Origen Cardiac Resynchronization Therapy Defibrillators |
Normal 180 Day Track |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2021-10-06 |
P960004-S098 |
Ventak Av Aicd Ventak Prizm Dr/Vr, Vitality, Cofient, and Teligen Automatic Implantable Cardioveter Defribillator System |
30-Day Notice |
NVN |
— |
— |
| 2021-10-06 |
P910073-S167 |
Endoktak Lead System |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-10-06 |
P110042-S163 |
Subcutaneous Implantable Defibrillator (S-ICD) System |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-10-06 |
P010012-S546 |
Contak CD, EasyTrak, Livian, Cognis, and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibril |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2021-10-05 |
P900056-S194 |
Rotablatorand ROTAPRO Rotational Atherectomy System, RotaWire Guidewire and wireClip Torquer, ROTAWIRE Drive Guidew |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2021-10-04 |
P960006-S054 |
Sweet Tip (R) Rx Steroid Eluting Lead |
30-Day Notice |
NVN |
— |
— |
| 2021-10-04 |
P960004-S097 |
Thinline Endocardial Pacing Leads |
30-Day Notice |
NVN |
— |
— |
| 2021-10-04 |
P910073-S166 |
Endotak Lead System |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-10-04 |
P830060-S087 |
Ventak and Automatic Implantable Cardioverter Defibrillator (AICD) Systems |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-10-04 |
P150012-S118 |
Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-10-04 |
P150003-S079 |
SYNERGY XD Everolimus Eluting Platinum Chromium Coronary Stent System |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2021-09-24 |
P960040-S470 |
ORIGEN VR, ORIGEN DR, INOGEN DR, INOGEN VR, DYNAGEN VR, DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM EL ICD DR, VIGILANT EL |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-09-24 |
P960006-S053 |
SWEET TIP Rx, SWEET PICOTIP Rx, and FLEXTEND |
30-Day Notice |
NVN |
— |
— |
| 2021-09-24 |
P960004-S096 |
FNLN2 SXP BP, FNLN2 SXP PF BP, FNLN2 SX PF BP, FNLN2 SXP J BP, |
30-Day Notice |
NVN |
— |
— |
| 2021-09-24 |
P960004-S095 |
THINLINE / FINELINE Family of Endocardial Pacing Leads |
30-Day Notice |
NVN |
— |
— |
| 2021-09-24 |
P910073-S164 |
REL S, REL, REL SEZ, REL EZ DUAL COIL, REL SG, REL G, SEN |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-09-24 |
P910073-S163 |
ENDOTAK Lead System |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-09-24 |
P150012-S117 |
ESSENTIO MRI SR, ESSENTIO MRI DR, PROPONENT MRI SR, PROPONENT MRI DR, ACCOLADE MRI SR, ACCOLADE MRI DR, INGEVITY PLUS AF |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-09-24 |
P150012-S115 |
INGEVITY and INGEVITY MRI Leads and Accessories; VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-09-24 |
P110042-S162 |
S-ICD GEN 2, S-ICD EMBLEM, EMBLEM S-ICD ELECTRODE |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-09-24 |
P110042-S158 |
S-ICD, Q-TRAK Subcutaneous Electrode, Q-TECH Programmer and Related Accessories |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-09-24 |
P010012-S545 |
EZTRK 2, ACUITY SPIRAL, ORIGEN CRT-D, INOGEN CRT-D, DYNAGEN CRT-D, NAV 2 QUADPOLE, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, VI |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2021-09-24 |
P010012-S542 |
CONTAK CD, CONTAK RENEWAL, LIVIAN, COGNIS, ENERGEN CRT-D, PUNCTUA CRT-D, INCEPTA CRT-D, ORIGEN CRT-D, INOGEN CRT-D, DYNA |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2021-09-24 |
N970003-S268 |
ESSENTIO SR, ESSENTIO DR, PROPONENT SR, PROPONENT DR, ACCOLADE SR, ACCOLADE DR, ALTRUA 2 DR, ALTRUA 2 SR |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-09-22 |
P950020-S113 |
Wolverine Coronary Cutting Balloon |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2021-09-22 |
P150003-S078 |
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Coro |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2021-09-22 |
P110010-S198 |
Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System; Promus ELITE Everolimus-Eluting Platinum Chro |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2021-09-20 |
P960040-S469 |
ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, ICD AUTOGEN VR, ICD AUTOGEN |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-09-20 |
P010012-S544 |
ICD ORIGEN CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, ICD AUTOGEN CRT-D |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2021-09-17 |
P960040-S465 |
TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-09-17 |
P910077-S185 |
LATITUDE NXT Remote Patient Management System, LATITUDEWave Communicator, LATITUDE Consult Communicator, LATITUDE NX |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-09-17 |
P150012-S114 |
INGENIO MRI, VITALIO MRI, VORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-09-17 |
P110042-S157 |
EMBLEM S-ICD |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-09-17 |
P010012-S539 |
COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT |
Real-Time Process |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2021-09-17 |
N970003-S266 |
ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-09-16 |
P190006-S027 |
Axonics Sacral Neuromodulation System |
135 Review Track For 30-Day Notice |
QON |
— |
— |
| 2021-09-16 |
P180046-S027 |
Axonics Sacral Neuromodulation System |
135 Review Track For 30-Day Notice |
EZW |
— |
— |
| 2021-09-13 |
P180011-S044 |
Eluvia Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2021-09-13 |
P140028-S068 |
Innova Vascular Self-Expanding Stent System |
30-Day Notice |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2021-09-10 |
P180011-S045 |
Eluvia Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2021-09-10 |
P140028-S069 |
Innova Self-Expanding Stent System |
30-Day Notice |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2021-09-09 |
P130013-S046 |
WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2021-09-08 |
N970012-S189 |
AMS 700 Inflatable Penile Prosthesis with and without InhibiZone |
30-Day Notice |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2021-09-07 |
P920047-S125 |
IntellaNav ST |
30-Day Notice |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2021-09-07 |
P150005-S067 |
IntellaNav Open Irrigated Ablation Catheters, IntellaNav MiFi Open-Irrigated Ablation Catheters |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2021-09-07 |
P020025-S133 |
IntellaNav MiFi XP, IntellaNav XP |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2021-09-03 |
P150012-S112 |
ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-09-03 |
N970003-S265 |
ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-08-25 |
P130013-S045 |
WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System (FLX) |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2021-08-19 |
P200029-S002 |
TheraSphere |
Real-Time Process |
NAW |
Microspheres Radionuclide |
Unknown |
| 2021-08-17 |
P020025-S132 |
IntellaTip MiFi Filter Module, IntellaTip MiFi Reference Cable, EGM Cable, Maestro 4000 Footswitch |
Real-Time Process |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2021-08-16 |
P110010-S197 |
PROMUS Premier and PROMUS Elite Everolimus-Eluting Platinum Chromium Coronary Stent System |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2021-08-12 |
P980037-S086 |
AngioJet Thrombectomy System |
Normal 180 Day Track No User Fee |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2021-08-12 |
P140008-S022 |
ORBERA Intragastric Balloon (IGB) System |
Real-Time Process |
LTI |
Implant, Intragastric For Morbid Obesity |
Unknown |
| 2021-08-11 |
P980037-S085 |
AngioJet Thrombectomy System |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2021-08-06 |
P150005-S066 |
Blazer Open Irrigated Ablation Catheter |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2021-08-05 |
P920047-S124 |
IntellaNav ST Ablation Catheter, Blazer II Temperature Ablation Catheter, Blazer II HTD Temperature Ablation Catheter, a |
Normal 180 Day Track |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2021-08-05 |
P150005-S061 |
Blazer Open-Irrigated Ablation Catheter, IntellaNav Open-Irrigated Ablation Catheter, IntellaNav MiFi Open-Irrigated Abl |
Normal 180 Day Track |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2021-08-05 |
P020025-S129 |
Blazer II XP Temperature Ablation Catheter, Blazer Prime XP Temperature Ablation Catheter, IntellaTip MiFi XP Temperatur |
Normal 180 Day Track |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2021-08-04 |
P180011-S043 |
Eluvia Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2021-07-23 |
P960040-S467 |
VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM |
Normal 180 Day Track No User Fee |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-07-23 |
P010012-S541 |
CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL |
Normal 180 Day Track No User Fee |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2021-07-21 |
P150005-S065 |
MetriQ Irrigation Tubing Set |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2021-07-20 |
P150005-S064 |
IntellaNav MiFi Open-Irrigated Ablation Catheters, IntellaTip MiFi Open-Irrigated Ablation Catheters, IntellaNav Open-Ir |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2021-07-14 |
P150012-S113 |
INGEVITY Passive Fixation leads |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-07-14 |
P150005-S063 |
Blazer Open-Irrigated Ablation Catheter |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2021-07-12 |
P030017-S344 |
Precision Spectra Spinal Cord Stimulator (SCS) System, Precision Novi Spinal Cord Stimulator (SCS) System, Precision Mon |
Normal 180 Day Track |
LGW |
— |
— |
| 2021-07-08 |
P000053-S121 |
AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone Treatment |
30-Day Notice |
EZY |
Device, Incontinence, Mechanical/Hydraulic |
Gastroenterology, Urology |
| 2021-07-08 |
N970012-S188 |
AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment |
30-Day Notice |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2021-07-06 |
P900056-S193 |
ROTAPRO Rotational Atherectomy System |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2021-07-02 |
P150003-S077 |
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire), SYNERGY XD Everolimus-E |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2021-07-02 |
P110010-S196 |
Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2021-07-01 |
P150003-S076 |
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire), SYNERGY XD Everolimus- |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2021-06-29 |
P180013-S007 |
VICI VENOUS STENT System |
Normal 180 Day Track No User Fee |
QAN |
Stent, Iliac Vein |
Unknown |
| 2021-06-24 |
P900056-S192 |
Rotablator Rotational Atherectomy System (Rotablator, RotaLink Plus, Rotalink Burr), ROTAPRO Rotational Atherectomy Syst |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2021-06-11 |
P190006-S025 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
QON |
— |
— |
| 2021-06-11 |
P180046-S025 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
EZW |
— |
— |
| 2021-06-10 |
P110042-S154 |
EMBLEM S-ICD Lead |
Normal 180 Day Track |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-06-08 |
P910073-S162 |
RELIANCE 4-FRONT Steroid-eluting Pace/Sense and Defibrillation Lead |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-06-02 |
P150031-S043 |
Vercise Deep Brain Stimulation Systems |
30-Day Notice |
NHL |
— |
— |
| 2021-06-02 |
P030017-S346 |
Precision Spinal Cord Stimulator Systems |
30-Day Notice |
LGW |
— |
— |
| 2021-05-27 |
P150003-S074 |
SYNERGY, SYNERGY XD and SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2021-05-27 |
P110010-S193 |
Promus Premier and Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent System |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2021-05-27 |
P080032-S018 |
Alair Bronchial Thermoplasty System |
30-Day Notice |
OOY |
Bronchial Thermoplasty System |
Unknown |
| 2021-05-27 |
P000053-S120 |
AMS 800 Series Product Line/Artificial Urinary Sphincter with and without InhibiZone Treatment |
30-Day Notice |
EZY |
Device, Incontinence, Mechanical/Hydraulic |
Gastroenterology, Urology |
| 2021-05-27 |
N970012-S187 |
AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment |
30-Day Notice |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2021-05-26 |
N970012-S186 |
AMS 700 Inflatable Penile Prosthesis |
30-Day Notice |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2021-05-25 |
P190006-S037 |
Axonics Sacral Neuromodulation (SNM) System for Bowel Control |
30-Day Notice |
QON |
— |
— |
| 2021-05-25 |
P180046-S037 |
Axonics Sacral Neuromodulation (SNM) System for Urinary Control |
30-Day Notice |
EZW |
— |
— |
| 2021-05-21 |
P130013-S042 |
WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System |
Normal 180 Day Track No User Fee |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2021-05-19 |
P190006-S024 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
QON |
— |
— |
| 2021-05-19 |
P180046-S024 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
EZW |
— |
— |
| 2021-05-18 |
P150003-S075 |
SYNERGY Everolimus Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire) |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2021-05-17 |
P130013-S044 |
WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2021-05-14 |
P200029-S001 |
TheraSphere |
Normal 180 Day Track No User Fee |
NAW |
Microspheres Radionuclide |
Unknown |
| 2021-05-13 |
P150031-S042 |
Vercise Genus Deep Brain Stimulation (DBS) System |
30-Day Notice |
NHL |
— |
— |
| 2021-05-13 |
P030017-S345 |
Wave Writer Alpha Spinal Cord Stimulator (SCS) System |
30-Day Notice |
LGW |
— |
— |
| 2021-05-12 |
P180011-S042 |
Eluvia Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2021-05-12 |
P110010-S192 |
Promus Premier and Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent System |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2021-05-10 |
P960006-S052 |
SWEET TIP(R) RX STEROID ELUTING LEAD |
30-Day Notice |
NVN |
— |
— |
| 2021-05-10 |
P960004-S094 |
THINLINE ENDOCARDIAL PACING LEADS |
30-Day Notice |
NVN |
— |
— |
| 2021-05-10 |
P930035-S032 |
VENTAK(R) P2 SYSTEM |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-05-10 |
P910077-S184 |
VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATOR |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-05-10 |
P910073-S161 |
ENDOTAK LEAD SYSTEM |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-05-10 |
P830060-S086 |
VENTAK AND AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-05-10 |
P150012-S111 |
IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-05-10 |
P010012-S538 |
CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2021-05-10 |
N970003-S264 |
PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-05-06 |
P960040-S464 |
ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI ICD DR |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-05-06 |
P150012-S110 |
ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, ACCOLADE MRI EL DR |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-05-06 |
P010012-S537 |
ORIGEN CRT-D, ORIGEN X4 CRT-D, MOMENTUM CRT-D, MOMENTUM, MOMENTUM X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, DYNAGEN CRT-D |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2021-05-06 |
N970003-S263 |
ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR, ACCOLAD |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-05-05 |
P140026-S018 |
ENROUTE® Transcarotid Stent System |
30-Day Notice |
NIM |
— |
— |
| 2021-04-30 |
P960040-S463 |
ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI ICD DR |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-04-30 |
P150012-S109 |
ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, ACCOLADE MRI EL DR |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-04-30 |
P110042-S156 |
SICD Gen 2, SICD MRI |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-04-30 |
P090003-S051 |
Express LD Iliac Premounted Stent System |
Real-Time Process |
NIO |
Stent, Iliac |
Unknown |
| 2021-04-30 |
P010012-S536 |
ORIGEN CRT-D, ORIGEN X4 CRT-D, MOMENTUM CRT-D, MOMENTUM, MOMENTUM X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, DYNAGEN CRT-D |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2021-04-30 |
N970003-S262 |
ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR, ACCOLAD |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-04-29 |
P150003-S073 |
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Coro |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2021-04-28 |
P010012-S534 |
ACUITY X4 Quadripolar Coronary Venous Pace/Sense Leads |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2021-04-23 |
P150031-S041 |
Deep Brain Stimulation (DBS) Systems - Vercise PC, Gevia and Genus Systems |
30-Day Notice |
NHL |
— |
— |
| 2021-04-23 |
P030017-S343 |
Precision Spinal Cord Stimulator (SCS) Systems |
30-Day Notice |
LGW |
— |
— |
| 2021-04-22 |
P110010-S191 |
Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2021-04-20 |
P190019-S008 |
Ranger Paclitaxel-Coated PTA Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2021-04-16 |
P830060-S084 |
Implantable Pulse Generator Test Magnet |
Normal 180 Day Track No User Fee |
OSR |
Pacemaker/Icd/Crt Non-Implanted Components |
Unknown |
| 2021-04-09 |
P010012-S535 |
ACUITY X4 Straight, ACUITY X4 Spiral S, ACUITY X4 Spiral L |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2021-04-08 |
P020025-S130 |
IntellaTip MiFi Filter Module and IntellaTip MiFi Reference Cable |
Normal 180 Day Track No User Fee |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2021-04-07 |
P110035-S066 |
Epic Self-Expanding Nitinol Vascular Stent with Delivery System |
30-Day Notice |
NIO |
Stent, Iliac |
Unknown |
| 2021-04-02 |
P960040-S462 |
VENTAK AV & VENTAK PRIZM DR/VR, VITALITY, CONFIENT, TELIGEN, PUNCTUA ICD, ENERGEN ICD, INCEPTA ICD, ORIGEN ICD, INOGEN I |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-04-02 |
P960006-S051 |
SWEET TIP Rx, SWEET PICOTIO Rx, and FLEXTEND |
30-Day Notice |
NVN |
— |
— |
| 2021-04-02 |
P960004-S093 |
THINLINE/FINELINE Family of Endocardial Pacing Leads |
30-Day Notice |
NVN |
— |
— |
| 2021-04-02 |
P950001-S029 |
SELUTE Lead System |
30-Day Notice |
NVN |
— |
— |
| 2021-04-02 |
P940031-S079 |
VIGOR DR/SR, DISCOVERY, and MERIDIAN |
30-Day Notice |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2021-04-02 |
P930035-S031 |
VENTAK P2 System |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-04-02 |
P910077-S183 |
VENTAK PRx and VENTAK MINI |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-04-02 |
P910073-S160 |
ENDOTAK Lead System |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-04-02 |
P890061-S024 |
VENTAK P |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-04-02 |
P840068-S055 |
DELTA/VISTA |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-04-02 |
P830060-S085 |
VENTAK |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-04-02 |
P830026-S083 |
COSMOS System |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-04-02 |
P150012-S108 |
INGEVITY MRI Pace/Sense Leads |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-04-02 |
P150012-S107 |
INGEVITY and INGEVITY MRI Leads and Accessories; VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-04-02 |
P110042-S155 |
EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-04-02 |
P110042-S153 |
S-ICD, Q-TRAK Subcutaneous Electrode, Q-Tech Programmer and Related Accessories |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-04-02 |
P010012-S533 |
Contak CD, Contak Renewal, Livian, Cognis, Energen CRT-D, Punctua CRT-D, Incepta CRT-D, Origen CRT-D, Inogen CRT-D, Dyna |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2021-04-02 |
N970003-S261 |
Pulsar, Pulsar Max, Discovery, Nexus, Intelis, Insignia, Altrua, Advantio, Ingenio, Vitalio, Formio, Essentio, Proponent |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-04-01 |
P190019-S009 |
Ranger Paclitaxel-Coated Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2021-03-30 |
P180029-S030 |
LOTUS Edge Valve System |
Normal 180 Day Track No User Fee |
NPT |
— |
— |
| 2021-03-30 |
P140026-S017 |
ENROUTE TRANSCAROTID STENT SYSTEM |
Special (Immediate Track) |
NIM |
— |
— |
| 2021-03-25 |
P190006-S034 |
Axonics Sacral Neuromodulation (SNM) System Bowel Control |
30-Day Notice |
QON |
— |
— |
| 2021-03-25 |
P180046-S034 |
Axonics Sacral Neuromodulation (SNM) System Urinary Control |
30-Day Notice |
EZW |
— |
— |
| 2021-03-24 |
P150003-S072 |
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Coro |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2021-03-24 |
P130030-S072 |
REBEL Platinum Chromium Coronary Stent System |
30-Day Notice |
MAF |
Stent, Coronary |
Unknown |
| 2021-03-24 |
P130013-S038 |
BSC WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System |
135 Review Track For 30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2021-03-24 |
P110010-S190 |
Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus ELITE Everolimus-Eluting Platinum Chro |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2021-03-19 |
P150003-S071 |
SYNERGY MEGATRON Everolimus Eluting Platinum Chromium Coronary Stent System |
Normal 180 Day Track No User Fee |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2021-03-17 |
P200029 |
TheraSphere |
Original |
NAW |
Microspheres Radionuclide |
Unknown |
| 2021-03-16 |
P190006-S033 |
Axonics Sacral Neuromodulation (SNM) System for Urinary Control |
30-Day Notice |
QON |
— |
— |
| 2021-03-16 |
P180046-S033 |
Axonics Sacral Neuromodulation (SNM) System for Bowel Control |
30-Day Notice |
EZW |
— |
— |
| 2021-03-16 |
N970012-S185 |
AMS 700 Inflatable Penile Prosthesis |
30-Day Notice |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2021-03-15 |
P190019-S007 |
Ranger Over-The-Wire Paclitaxel-Coated PTA Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2021-03-05 |
P150003-S070 |
SYNERGY, SYNERGY XD and SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2021-03-05 |
P110010-S189 |
PROMUS Elite Everolimus-Eluting Platinum Chromium Coronary Stent System |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2021-03-04 |
P190006-S032 |
Axonics Sacral Neuromodulation (SNM) System for Urinary Control |
30-Day Notice |
QON |
— |
— |
| 2021-03-04 |
P180046-S032 |
Axonics Sacral Neuromodulation (SNM) System for Bowel Control |
30-Day Notice |
EZW |
— |
— |
| 2021-03-03 |
P180011-S041 |
ELUVIA Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2021-03-03 |
P150005-S062 |
MetriQ Pump |
Normal 180 Day Track No User Fee |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2021-03-03 |
P140028-S067 |
Innova Self Expanding Stent System |
30-Day Notice |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2021-03-03 |
P110035-S065 |
Epic Self Expanding Stent System |
30-Day Notice |
NIO |
Stent, Iliac |
Unknown |
| 2021-03-02 |
P190006-S031 |
Axonics Sacral Neuromodulation (SNM) System for Urinary Control |
30-Day Notice |
QON |
— |
— |
| 2021-03-02 |
P180046-S031 |
Axonics Sacral Neuromodulation (SNM) System for Bowel Control |
30-Day Notice |
EZW |
— |
— |
| 2021-03-01 |
P190006-S030 |
Axonics Sacral Neuromodulation (SNM) System Urinary Control |
30-Day Notice |
QON |
— |
— |
| 2021-03-01 |
P180046-S030 |
Axonics Sacral Neuromodulation (SNM) System for Bowel Control |
30-Day Notice |
EZW |
— |
— |
| 2021-02-24 |
P190019-S006 |
Ranger Paclitaxel-Coated PTA Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2021-02-24 |
P180046-S029 |
Axonics Sacral Neuromodulation (SNM) System for Bowel Control |
30-Day Notice |
EZW |
— |
— |
| 2021-02-24 |
P110010-S188 |
PROMUS Everolimus-Eluting Coronary Stent System |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2021-02-24 |
P010012-S532 |
ACUITY X4 Straight, ACUITY X4 Spiral S, ACUITY X4 Spiral L |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2021-02-23 |
P190006-S029 |
Axonics Sacral Neuromodulation (SNM) System for Urinary Control |
30-Day Notice |
QON |
— |
— |
| 2021-02-11 |
P180013-S006 |
VICI VENOUS STENT System and VICI RDS Stent System |
Normal 180 Day Track No User Fee |
QAN |
Stent, Iliac Vein |
Unknown |
| 2021-02-10 |
P190019-S003 |
Ranger Paclitaxel-Coated PTA Balloon Catheter |
Real-Time Process |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2021-02-10 |
P130013-S041 |
WATCHMAN and WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System |
Special (Immediate Track) |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2021-02-05 |
P900056-S183 |
Rotablator or ROTAPRO Rotational Atherectomy System |
Normal 180 Day Track |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2021-02-05 |
P110010-S187 |
PROMUS Element Plus Everolimus-Eluting Coronary Stent System, Promus PREMIER Everolimus-Eluting Coronary Stent System, P |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2021-02-03 |
P190006-S026 |
Axonics Sacral Neuromodulation System |
Real-Time Process |
QON |
— |
— |
| 2021-02-03 |
P180046-S026 |
Axonics Sacral Neuromodulation System |
Real-Time Process |
EZW |
— |
— |
| 2021-02-02 |
P960040-S460 |
Ventak AV AICD, Ventak Prizm DR/VR, Vitality, Cofient, and Teligen Automatic Implantable Cardioveter Defibrillator Syste |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-02-02 |
P910077-S182 |
LATITUDE Programming System |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-02-02 |
P150012-S104 |
Imageready MR Conditional Pacing System and Ingevity PACE/SENSE Lead |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-02-02 |
P110042-S150 |
Subcutaneous Implantable Defibrillator(S-ICD) System |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-02-02 |
P010012-S529 |
Contak CD, Easytrak, Livian, Cognis and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibrill |
Real-Time Process |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2021-02-02 |
N970003-S259 |
Pulsar/Pulsar Max Implantable Pulse Generator System with Consult Software |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-01-22 |
P150003-S054 |
SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System |
Normal 180 Day Track |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2021-01-21 |
P150031-S034 |
Vercise Genus Deep Brain Stimulation (DBS) System |
Normal 180 Day Track |
NHL |
— |
— |
| 2021-01-14 |
P170023-S008 |
Bulkamid Urethral Bulking System |
30-Day Notice |
LNM |
Agent, Bulking, Injectable For Gastro-Urology Use |
Unknown |
| 2021-01-13 |
P960006-S050 |
FLEXTEND® Bipolar, Steroid Eluting, Extendable/Retractable Pacing Lead |
30-Day Notice |
NVN |
— |
— |
| 2021-01-13 |
P960004-S092 |
FINELINE II Sterox, Endocardial Pacing Lead, Passive Fixation |
30-Day Notice |
NVN |
— |
— |
| 2021-01-13 |
P910073-S159 |
Endotak Lead System |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-01-13 |
P150012-S106 |
INGEVITY non-MRI Lead Passive Fixation, Preformed Atrial J, INGEVITY non-MRI Lead Passive Fixation, Ventricular, INGEV |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-01-13 |
P110042-S152 |
EMBLEM S-ICD Subcutaneous Electrode |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-01-13 |
P010012-S531 |
EASYTRAK® 2 1S-1 Coronary Venous Steroid-Eluting Bipolar Pace/Sense Lead, EASYTRAK® 3 IS-1 Coronary Venous Steroid-Eluti |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2021-01-07 |
P190019-S005 |
Ranger Paclitaxel-Coated PTA Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2020-12-29 |
P150031-S028 |
Vercise Deep Brain Stimulation (DBS) System |
Panel Track |
NHL |
— |
— |
| 2020-12-18 |
P150005-S058 |
Blazer Open-Irrigated Ablation Catheter and IntellaNav Open-Irrigated Ablation Catheter |
Normal 180 Day Track |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2020-12-17 |
P980037-S084 |
AngioJet Thrombectomy Catheter |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2020-12-17 |
P180011-S040 |
Eluvia Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2020-12-17 |
P170023-S007 |
Bulkamid Urethral Bulking System |
30-Day Notice |
LNM |
Agent, Bulking, Injectable For Gastro-Urology Use |
Unknown |
| 2020-12-17 |
P140028-S066 |
Innova Vascular Self-Expanding Stent with Delivery System |
30-Day Notice |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2020-12-17 |
P130013-S040 |
WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2020-12-17 |
P110035-S064 |
Epic Vascular Self-Expanding Stent System |
30-Day Notice |
NIO |
Stent, Iliac |
Unknown |
| 2020-12-17 |
P000053-S119 |
AMS 800 Artificial Urinary Sphincter |
30-Day Notice |
EZY |
Device, Incontinence, Mechanical/Hydraulic |
Gastroenterology, Urology |
| 2020-12-17 |
N970012-S184 |
700 Inflatable Penile Prosthesis and AMS Ambicor Penile Prosthesis |
30-Day Notice |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2020-12-16 |
P950020-S111 |
Wolverine Coronary Cutting Balloon |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2020-12-16 |
P190019-S004 |
Ranger Paclitaxel-Coated PTA Balloon Catheter |
Normal 180 Day Track No User Fee |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2020-12-16 |
P150003-S068 |
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System and SYNERGY XD Everolimus-Eluting Platinum Chromium C |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2020-12-16 |
P130013-S039 |
WATCHMAN Left Atrial Appendage Closure Device with Delivery System |
Real-Time Process |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2020-12-16 |
P110010-S185 |
Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System and Promus ELITE Everolimus-Eluting Platinum C |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2020-12-15 |
P150005-S060 |
Blazer OI, IntellaNav OI, IntellaTip MiFi OI, and IntellaNav MiFi OI |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2020-12-11 |
P960040-S461 |
Ventak AV AICD Ventak Prizm DR/VR, Vitality, Cofient, and Teligen Automatic Implantable Cardioverter Defibrillator Syste |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-12-11 |
P150012-S105 |
ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, and ACCOLADE MRI EL D |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-12-11 |
P150005-S059 |
Blazer OI Catheter, IntellaNav OI Catheter, IntellaNav MiFi OI Catheter, IntellaTip MiFi OI Catheter |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2020-12-11 |
P110042-S151 |
Subcutaneous Implantable Defibrillator (S-ICD) System |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-12-11 |
P010012-S530 |
Contak CD, Easytrak, Livian, Cognis and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibrill |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2020-12-11 |
P000053-S118 |
AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone Treatment |
30-Day Notice |
EZY |
Device, Incontinence, Mechanical/Hydraulic |
Gastroenterology, Urology |
| 2020-12-11 |
N970003-S260 |
ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR, ACCOL |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-12-08 |
P180011-S039 |
ELUVIA Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2020-12-08 |
P150003-S069 |
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire) |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2020-12-08 |
P140028-S065 |
Innova Vascular Self-Expanding Stent System |
30-Day Notice |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2020-12-08 |
P130030-S071 |
REBEL Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire) |
30-Day Notice |
MAF |
Stent, Coronary |
Unknown |
| 2020-12-08 |
P110010-S186 |
Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2020-12-04 |
P960040-S456 |
VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM |
Normal 180 Day Track No User Fee |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-12-04 |
P910073-S158 |
ENDOTAK LEAD SYSTEM |
Normal 180 Day Track No User Fee |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-12-04 |
P010012-S525 |
CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL |
Normal 180 Day Track No User Fee |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2020-12-02 |
P190019-S001 |
Ranger Paclitaxel-Coated PTA Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2020-12-02 |
P170023-S005 |
Bulkamid Urethral Bulking System |
Real-Time Process |
LNM |
Agent, Bulking, Injectable For Gastro-Urology Use |
Unknown |
| 2020-12-02 |
P140008-S019 |
ORBERA Intragastric Balloon System |
Normal 180 Day Track No User Fee |
LTI |
Implant, Intragastric For Morbid Obesity |
Unknown |
| 2020-12-01 |
P110042-S148 |
EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-12-01 |
P030017-S338 |
WaveWriter Alpha Spinal Cord Stimulator (SCS) System |
Normal 180 Day Track |
LGW |
— |
— |
| 2020-11-30 |
P180011-S038 |
Eluvia Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2020-11-30 |
P150003-S066 |
SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium C |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2020-11-30 |
P110035-S063 |
Epic Self Expanding Stent System |
30-Day Notice |
NIO |
Stent, Iliac |
Unknown |
| 2020-11-30 |
P110010-S183 |
Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus ELITE Everolimus-Eluting Platinum Chro |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2020-11-23 |
P900056-S191 |
Rotablator Rotational Atherectomy System and ROTAPRO Rotational Atherectomy System |
Normal 180 Day Track No User Fee |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2020-11-20 |
P950020-S110 |
WOLVERINE Cutting Balloon Micro-Surgical Dilation Catheter |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2020-11-19 |
P150003-S067 |
SYNERGY Everolimus-Eluting Platinum Chromium Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Sten |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2020-11-19 |
P110010-S184 |
Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus ELITE Everolimus-Eluting Platinum Coro |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2020-11-18 |
P090003-S050 |
Express LD Iliac Premounted Stent System |
30-Day Notice |
NIO |
Stent, Iliac |
Unknown |
| 2020-11-18 |
P060006-S102 |
Express SD Renal Premounted Stent System |
30-Day Notice |
NIN |
Stent, Renal |
Unknown |
| 2020-11-16 |
P150012-S103 |
ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-11-16 |
P110042-S147 |
EMBLEM S-ICD Pulse Generator and EMBLEM MRI S-ICD Pulse Generator |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-11-16 |
N970003-S258 |
ALTRUA 2, ESSENTIO, PROPONENT, and ACCOLADE |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-11-12 |
P980037-S083 |
AngioJet Rheolytic Thrombectomy System |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2020-11-12 |
P960040-S457 |
VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM |
Normal 180 Day Track No User Fee |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-11-12 |
P190019-S002 |
Ranger Paclitaxel-Coated PTA Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2020-11-12 |
P010012-S526 |
CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL |
Normal 180 Day Track No User Fee |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2020-11-06 |
P180029-S028 |
LOTUS Edge Valve System |
30-Day Notice |
NPT |
— |
— |
| 2020-11-05 |
P960040-S458 |
ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-11-05 |
P190006-S023 |
Axonics Sacral Neuromodulation System (Urinary) |
30-Day Notice |
QON |
— |
— |
| 2020-11-05 |
P190006-S022 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2020-11-05 |
P180046-S023 |
Axonics Sacral Neuromodulation System (Bowel) |
30-Day Notice |
EZW |
— |
— |
| 2020-11-05 |
P180046-S022 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2020-11-05 |
P110042-S149 |
S-ICD GEN 2 and S-ICD EMBLEM MRI |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-11-05 |
P010012-S527 |
ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, ICD AUTOGEN CRT-D, VIGILANT CR |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2020-10-30 |
P190019 |
Ranger Paclitaxel-Coated PTA Balloon Catheter |
Original |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2020-10-30 |
P000053-S117 |
AMS 800 Artificial Urinary Sphincter with and without InhibiZone Treatment |
30-Day Notice |
EZY |
Device, Incontinence, Mechanical/Hydraulic |
Gastroenterology, Urology |
| 2020-10-30 |
N970012-S183 |
AMS 700 Implantable Penile Prosthesis with and without Inhibizone Treatment |
30-Day Notice |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2020-10-29 |
P980037-S082 |
AngioJet Rheolytic Thrombectomy Catheter |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2020-10-22 |
P960040-S455 |
ICD AUTOGEN DR, ICD AUTOGEN VR, ICD DYNAGEN DR, ICD DYNAGEN VR, ICD INOGEN DR, ICD INOGEN VR, ICD ORIGEN DR, ICD ORIGEN |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-10-22 |
P960040-S453 |
TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA - ICD Device |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-10-22 |
P910077-S180 |
LATITUDE NXT Patient Management System, LATITUDE Wave Communicator, LATITUDE Consult Communicator, LATITUDE NXT Syst |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-10-22 |
P170023-S003 |
Bulkamid Urethral Bulking System |
Real-Time Process |
LNM |
Agent, Bulking, Injectable For Gastro-Urology Use |
Unknown |
| 2020-10-22 |
P150012-S102 |
PG ACCOLADE MRI DR, PG ACCOLADE MRI SR, PG ESSENTIO MRI DR, PG ESSENTIO MRI SR, PG PROPONENT MRI DR, and PG PROPONENT M |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-10-22 |
P150012-S099 |
INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIOMRI, PROPONENT MRI, ACCOLADE MRI - Pacemaker Devices |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-10-22 |
P110042-S142 |
EMBLEM S-ICD - Subcutaneous Devices |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-10-22 |
P010012-S524 |
ICD AUTOGEN CRT-D, ICD DYNAGEN CRT-D, ICD INOGEN CRT-D, ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, RESONATE CR |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2020-10-22 |
P010012-S522 |
COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT - CRT-D Resynchroniza |
Real-Time Process |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2020-10-22 |
N970003-S257 |
PG ACCOLADE DR, PG ACCOLADE SR, PG ALTRUA 2 DR, PG ALTRUA 2 SR, PG ESSENTIO DR, PG ESSENTIO SR, PG PROPONENT DR, and PG |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-10-22 |
N970003-S254 |
ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA and ALTRUA 2 supported by LATITUDE Consult |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-10-16 |
P150012-S100 |
ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI Pacemakers |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-10-16 |
P140008-S021 |
ORBERA Intragastric Balloon System |
Special (Immediate Track) |
LTI |
Implant, Intragastric For Morbid Obesity |
Unknown |
| 2020-10-16 |
P110042-S143 |
EMBLEM S-ICD Pulse Generator and EMBLEM MRI S-ICD Pulse Generator |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-10-16 |
N970003-S255 |
ALTRUA 2, ESSENTIO, PROPONENT, and ACCOLADE Pacemakers |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-10-13 |
P150003-S065 |
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System and SYNERGY XD Everolimus-Eluting Platinum Chromium C |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2020-10-13 |
P110010-S182 |
Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System and Promus Elite Everolimus-Eluting Platinum C |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2020-10-09 |
P190006-S020 |
Axonics Sacral Neuromodulation System |
Real-Time Process |
QON |
— |
— |
| 2020-10-09 |
P180046-S020 |
Axonics Sacral Neuromodulation System |
Real-Time Process |
EZW |
— |
— |
| 2020-10-09 |
P150005-S057 |
MetriQ Irrigation Tubing Set |
Real-Time Process |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2020-10-07 |
P180029-S027 |
LOTUS Edge Valve System |
30-Day Notice |
NPT |
— |
— |
| 2020-10-01 |
P960040-S454 |
ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, ICD ORIGEN VR, ICD ORIGEN DR |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-10-01 |
P150012-S101 |
PG ESSENTIO MRI SR, PG ESSENTIO MRI DR, PG PROPONENT MRI SR, PG PROPONENT MRI DR, PG ACCOLADE MRI SR, PG ACCOLADE MRI D |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-10-01 |
P110042-S146 |
S-ICD GEN 2, S-ICD EMBLEM MRI |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-10-01 |
P010012-S523 |
ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, ICD AUTOGEN CRT-D, VIGILANT CR |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2020-10-01 |
N970003-S256 |
PG ESSENTIO SR, PG ESSENTIO DR, PG PROPONENT SR, PG PROPONENT DR, PG ACCOLADE SR, PG ACCOLADE DR, PG ALTRUA 2 SR, PG ALT |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-09-30 |
P030017-S342 |
Precision Montage and Precision Montage MRI Spinal Cord Stimulator Systems |
30-Day Notice |
LGW |
— |
— |
| 2020-09-29 |
P900056-S189 |
Rotablator Rotational Atherectomy System and ROTAPRO Rotational Atherectomy System |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2020-09-29 |
P900056-S188 |
Rotablator Rotational Atherectomy System and ROTAPRO Rotational Atherectomy System |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2020-09-25 |
P960004-S091 |
FINELINE II Steroid-Eluting Pacing Leads |
30-Day Notice |
NVN |
— |
— |
| 2020-09-25 |
P900056-S190 |
Rotablator Rotational Atherectomy System |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2020-09-22 |
P950020-S109 |
WOLVERINE Coronary Cutting Balloon |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2020-09-22 |
P030017-S341 |
Precision Spinal Cord Stimulator (SCS) Systems |
30-Day Notice |
LGW |
— |
— |
| 2020-09-21 |
P190006-S021 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2020-09-21 |
P180046-S021 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2020-09-17 |
P910077-S181 |
LATITUDE Programming System (Programmer) |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-09-17 |
P180029-S026 |
LOTUS Edge Valve System |
30-Day Notice |
NPT |
— |
— |
| 2020-09-17 |
P150003-S063 |
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) |
Real-Time Process |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2020-09-17 |
P110042-S144 |
EMBLEM S-ICD Programmer |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-09-17 |
P110010-S180 |
Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System |
Real-Time Process |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2020-09-17 |
P000053-S116 |
AMS 800 Artificial Urinary Sphincter (AUS) with InhibiZone Treatment |
30-Day Notice |
EZY |
Device, Incontinence, Mechanical/Hydraulic |
Gastroenterology, Urology |
| 2020-09-16 |
N970012-S182 |
AMS 700 Inflatable Penile Prosthesis (IPP) with InhibiZone Treatment |
30-Day Notice |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2020-09-15 |
P180013-S002 |
VICI VENOUS STENT System |
Normal 180 Day Track No User Fee |
QAN |
Stent, Iliac Vein |
Unknown |
| 2020-09-10 |
P900056-S187 |
Rotablator Rotational Atherectomy System (Rotablator, RotaLink Plus) and ROTAPRO Rotational Atherectomy System (ROTAPRO, |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2020-09-10 |
P110042-S145 |
Subcutaneous Implantable Cardioverter Defibrillator |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-09-09 |
N970012-S181 |
AMS 700 Inflatable Penile Prosthesis with and without Inhibizone Treatment |
30-Day Notice |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2020-09-04 |
N970012-S180 |
AMS 700 Inflatable Penile Prosthesis and AMS 700 Inflatable Penile Prosthesis with InhibiZone Treatment |
30-Day Notice |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2020-09-03 |
P180013-S004 |
VICI VENOUS STENT System |
Normal 180 Day Track |
QAN |
Stent, Iliac Vein |
Unknown |
| 2020-09-03 |
P150012-S098 |
ESSENTIO, PROPONENT, ACCOLADE - MRI Pacemakers |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-09-03 |
N970003-S253 |
ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2 - Non MRI Pacemakers |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-09-02 |
P180011-S036 |
ELUVIA Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2020-09-02 |
P140028-S063 |
Innova Vascular Self-Expanding Stent System |
30-Day Notice |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2020-08-31 |
P190006-S015 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
QON |
— |
— |
| 2020-08-31 |
P180046-S015 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
EZW |
— |
— |
| 2020-08-28 |
P180011-S037 |
Eluvia Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2020-08-28 |
P140028-S064 |
Innova Vascular Self-Expanding Stent System |
30-Day Notice |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2020-08-28 |
P110035-S062 |
Epic Vascular Self-Expanding Stent System |
30-Day Notice |
NIO |
Stent, Iliac |
Unknown |
| 2020-08-26 |
P150012-S096 |
ImageReady MR Conditional Pacing System and INGEVITY Pace/Sense Lead |
Normal 180 Day Track No User Fee |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-08-26 |
P000053-S115 |
AMS 800 Artificial Urinary Sphincter and AMS 800 Artificial Urinary Sphincter with InhibiZone Treatment |
30-Day Notice |
EZY |
Device, Incontinence, Mechanical/Hydraulic |
Gastroenterology, Urology |
| 2020-08-20 |
P180029-S025 |
LOTUS Edge Valve System |
30-Day Notice |
NPT |
— |
— |
| 2020-08-20 |
P150003-S064 |
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire) |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2020-08-20 |
P130030-S070 |
REBEL Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) |
30-Day Notice |
MAF |
Stent, Coronary |
Unknown |
| 2020-08-20 |
P110010-S181 |
Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2020-08-17 |
P180029-S020 |
LOTUS Edge Valve System |
135 Review Track For 30-Day Notice |
NPT |
— |
— |
| 2020-08-17 |
P060006-S101 |
Express SD Renal Premounted Stent System |
30-Day Notice |
NIN |
Stent, Renal |
Unknown |
| 2020-08-14 |
P150031-S038 |
Vercise, Vercise PC, and Vercise Gevia Deep Brain Stimulation (DBS) System |
30-Day Notice |
NHL |
— |
— |
| 2020-08-12 |
P150031-S036 |
Vercise Deep Brain Stimulation (DBS) Systems |
Special (Immediate Track) |
NHL |
— |
— |
| 2020-08-11 |
P150031-S037 |
Vercise Deep Brain Stimulation (DBS) System and Vercise Gevia Deep Brain Stimulation (DBS) System |
30-Day Notice |
NHL |
— |
— |
| 2020-08-11 |
P030017-S340 |
Precision Spinal Cord Stimulator (SCS) System, Precision Spectra Spinal Cord Stimulator (SCS) System, Spectra Wave Write |
30-Day Notice |
LGW |
— |
— |
| 2020-08-10 |
P980037-S081 |
AngioJet Rheolytic Thrombectomy Catheter |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2020-08-10 |
P150003-S058 |
Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) |
Panel Track |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2020-08-06 |
P110042-S140 |
EMBLEM S-ICD Pulse Generator |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-08-03 |
P960040-S452 |
ORIGEN, INOGEN, DYNAGEN MINI ICD VR/DR, ORIGEN, MOMENTUM, INOGEN, DYNAGEN, VIGILANT, RESONATE EL ICD VR/DR, ICD AUTOGEN, |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-08-03 |
P150012-S097 |
IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-08-03 |
P110042-S141 |
SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-08-03 |
P010012-S521 |
CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2020-08-03 |
N970003-S252 |
PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-07-30 |
P180011-S034 |
Eluvia Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2020-07-30 |
P140028-S061 |
Innova Vascular Self-Expanding Stent with Delivery System |
30-Day Notice |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2020-07-30 |
P110035-S060 |
Epic Vascular Self-Expanding Stent System |
30-Day Notice |
NIO |
Stent, Iliac |
Unknown |
| 2020-07-30 |
P000053-S114 |
AMS 800 Artificial Urinary Sphincter |
30-Day Notice |
EZY |
Device, Incontinence, Mechanical/Hydraulic |
Gastroenterology, Urology |
| 2020-07-30 |
N970012-S179 |
AMS 700 Inflatable Penile Prosthesis and AMS Ambicor Penile Prosthesis |
30-Day Notice |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2020-07-28 |
P190006-S019 |
Axonics Sacral Neuromodulation (SNM) System |
30-Day Notice |
QON |
— |
— |
| 2020-07-28 |
P180046-S019 |
Axonics Sacral Neuromodulation (SNM) System |
30-Day Notice |
EZW |
— |
— |
| 2020-07-22 |
P980033-S058 |
Wallstent (Venous) Endoprosthesis With Unistep Plus Delivery System |
30-Day Notice |
QKJ |
Stent, Central Venous |
Unknown |
| 2020-07-22 |
P930031-S068 |
Wallstent (Tips) Endoprosthesis With Unistep Plus Delivery System |
30-Day Notice |
MIR |
Shunt, Portosystemic, Endoprosthesis |
Unknown |
| 2020-07-22 |
P110042-S139 |
EMBLEM Subcutaneous Implantable Cardioverter Defibrillator S-ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-07-22 |
P110035-S061 |
EPIC Self Expanding Stent System |
30-Day Notice |
NIO |
Stent, Iliac |
Unknown |
| 2020-07-21 |
P190006-S014 |
Axonics Sacral Neuromodulation System |
Real-Time Process |
QON |
— |
— |
| 2020-07-21 |
P180046-S013 |
Axonics Sacral Neuromodulation System |
Real-Time Process |
EZW |
— |
— |
| 2020-07-21 |
P130013-S035 |
WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System and WATCHMAN Left Atrial Appendage Closure Device |
Panel Track |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2020-07-20 |
P180011-S035 |
Eluvia Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2020-07-20 |
P140028-S062 |
Innova Vascular Self-Expanding Stent System |
30-Day Notice |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2020-07-16 |
P900056-S186 |
Rotablator Rotational Atherectomy System and ROTAPRO Rotational Atherectomy System |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2020-07-10 |
P190006-S017 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2020-07-10 |
P180046-S017 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2020-07-10 |
P180011-S033 |
Eluvia Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2020-07-08 |
P190006-S018 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2020-07-08 |
P180046-S018 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2020-07-07 |
P910077-S178 |
LATITUDE Programming System |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-07-07 |
P910073-S157 |
RELIANCE 4-FRONT |
Normal 180 Day Track No User Fee |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-07-07 |
P110042-S137 |
EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) System |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-07-07 |
P010012-S520 |
ACUITY X4 |
Normal 180 Day Track No User Fee |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2020-07-02 |
P190006-S016 |
Axonics SNM System |
30-Day Notice |
QON |
— |
— |
| 2020-07-02 |
P180046-S016 |
Axonics SNM System |
30-Day Notice |
EZW |
— |
— |
| 2020-07-01 |
P190006-S011 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
QON |
— |
— |
| 2020-07-01 |
P180046-S011 |
Axonics Sacral Neuromodulation System |
Normal 180 Day Track |
EZW |
— |
— |
| 2020-07-01 |
P130030-S069 |
REBEL Platinum Chromium Coronary Stent System Monorail and Over-the-Wire |
30-Day Notice |
MAF |
Stent, Coronary |
Unknown |
| 2020-06-29 |
P150031-S031 |
Vercise Deep Brain Stimulation (DBS) System |
Real-Time Process |
NHL |
— |
— |
| 2020-06-25 |
P980033-S057 |
Wallstent (Venous) Endoprosthesis With Unistep Plus Delivery System |
30-Day Notice |
QKJ |
Stent, Central Venous |
Unknown |
| 2020-06-25 |
P930031-S067 |
Wallstent (Tips) Endoprosthesis With Unistep Plus Delivery System |
30-Day Notice |
MIR |
Shunt, Portosystemic, Endoprosthesis |
Unknown |
| 2020-06-19 |
P150012-S095 |
Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead |
Normal 180 Day Track No User Fee |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-06-17 |
P180029-S022 |
LOTUS Edge Valve System |
Real-Time Process |
NPT |
— |
— |
| 2020-06-17 |
P020025-S128 |
IntellaNav XP and IntellaNav MiFi XP ablation catheters |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2020-06-16 |
P900056-S185 |
Rotablator Rotational Atherectomy System, ROTAPRO Rotational Atherectomy System |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2020-06-16 |
P000053-S113 |
AMS 800 Series Product Line/Artificial Urinary Sphincter with and without InhibiZone Treatment |
30-Day Notice |
EZY |
Device, Incontinence, Mechanical/Hydraulic |
Gastroenterology, Urology |
| 2020-06-16 |
N970012-S178 |
AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without Inhibizone Treatment |
30-Day Notice |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2020-06-15 |
P960040-S450 |
(ICD Devices) TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIV |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-06-15 |
P910077-S177 |
LATITUDE Programming System, Altrua/Insignia I/Nexus I |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-06-15 |
P150012-S092 |
(Pacemaker Devices) INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-06-15 |
P010012-S518 |
(CRT-D Resynchronization Devices) COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTU |
Real-Time Process |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2020-06-15 |
N970003-S251 |
(Pacemaker Devices) ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, ALTRUA, INSIGNIA I, NEXUS I |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-06-12 |
P950020-S108 |
WOLVERINE Coronary Cutting Balloon |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2020-06-12 |
P910077-S179 |
LATITUDE Wave Communicators |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-06-12 |
P180011-S032 |
ELUVIA Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2020-06-12 |
P140028-S060 |
Innova Vascular Self-Expanding Stent System |
30-Day Notice |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2020-06-11 |
P180029-S024 |
LOTUS Edge Valve System |
30-Day Notice |
NPT |
— |
— |
| 2020-06-09 |
P150003-S062 |
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2020-06-09 |
P110010-S179 |
Promus Premier, Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2020-06-04 |
P920047-S123 |
Blazer Prime XP cardiac ablation catheters |
Real-Time Process |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2020-06-04 |
P150005-S056 |
IntellaNav MiFi Open-Irrigated (OI) and IntellaTip MiFi OI ablation catheters |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2020-06-04 |
P140026-S014 |
ENROUTE Transcarotid Stent System |
Normal 180 Day Track No User Fee |
NIM |
— |
— |
| 2020-06-04 |
P020025-S127 |
Blazer Prime HTD cardiac ablation catheter |
Real-Time Process |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2020-06-02 |
P190006-S006 |
Axonics Sacral Neuromodulation System |
Real-Time Process |
QON |
— |
— |
| 2020-06-02 |
P180046-S006 |
Axonics Sacral Neuromodulation System |
Real-Time Process |
EZW |
— |
— |
| 2020-06-02 |
P170023-S001 |
Bulkamid Urethral Bulking System |
30-Day Notice |
LNM |
Agent, Bulking, Injectable For Gastro-Urology Use |
Unknown |
| 2020-06-01 |
P140026-S015 |
ENROUTE Transcarotid Stent System |
30-Day Notice |
NIM |
— |
— |
| 2020-05-29 |
P150005-S054 |
IntellaNav MiFi Open-Irrigated Ablation Catheter |
Normal 180 Day Track No User Fee |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2020-05-28 |
P150005-S055 |
IntellaNav OI, and IntellaNav MiFi OI |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2020-05-28 |
P150003-S055 |
SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) |
Normal 180 Day Track |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2020-05-28 |
P110042-S138 |
EMBLEM Subcutaneous Implantable Cardioverter-Defibrillator (S-ICD) |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-05-27 |
P150031-S035 |
VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM |
30-Day Notice |
NHL |
— |
— |
| 2020-05-27 |
P030017-S339 |
Precision Spinal Cord Stimulator(SCS) Systems |
30-Day Notice |
LGW |
— |
— |
| 2020-05-26 |
P180013-S005 |
VICI VENOUS STENT System |
Normal 180 Day Track No User Fee |
QAN |
Stent, Iliac Vein |
Unknown |
| 2020-05-21 |
P180011-S031 |
Eluvia Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2020-05-20 |
P000053-S112 |
AMS 800 Artificial Urinary Sphincter with and without InhibiZone Treatment |
Normal 180 Day Track No User Fee |
EZY |
Device, Incontinence, Mechanical/Hydraulic |
Gastroenterology, Urology |
| 2020-05-20 |
N970012-S177 |
AMS 700 Implantable Penile Prosthesis (IPP) with and without Inhibizone Treatment |
Normal 180 Day Track No User Fee |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2020-05-19 |
P980037-S079 |
AngioJet Rheolythic Thrombectomy Catheter |
Normal 180 Day Track No User Fee |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2020-05-19 |
P980003-S092 |
Chilli II Cooled Ablation Catheter and Cable |
Normal 180 Day Track No User Fee |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2020-05-19 |
P950020-S106 |
WOLVERINE Coronary Cutting Balloon |
Normal 180 Day Track No User Fee |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2020-05-19 |
P920047-S122 |
Blazer II Cardiac Ablation Catheter and Cable |
Normal 180 Day Track No User Fee |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2020-05-19 |
P900056-S184 |
Rotablator Rotational Angioplasty System Guidewire |
Normal 180 Day Track No User Fee |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2020-05-19 |
P180011-S028 |
Eluvia Drug-Eluting Vascular Stent System |
Normal 180 Day Track No User Fee |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2020-05-19 |
P150005-S053 |
Blazer Open Irrigated Temperature Ablation Catheter |
Normal 180 Day Track No User Fee |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2020-05-19 |
P150003-S059 |
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System |
Normal 180 Day Track No User Fee |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2020-05-19 |
P140028-S056 |
Innova Self-Expanding Stent System |
Normal 180 Day Track No User Fee |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2020-05-19 |
P130030-S067 |
REBEL Platinum Chromium Coronary Stent System |
Normal 180 Day Track No User Fee |
MAF |
Stent, Coronary |
Unknown |
| 2020-05-19 |
P110035-S057 |
Epic Vascular Self-Expanding Stent System |
Normal 180 Day Track No User Fee |
NIO |
Stent, Iliac |
Unknown |
| 2020-05-19 |
P110010-S176 |
PROMUS Element PLUS/PREMIER/ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System |
Normal 180 Day Track No User Fee |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2020-05-19 |
P060006-S100 |
Express SD Monorail Premounted Stent System |
Normal 180 Day Track No User Fee |
NIN |
Stent, Renal |
Unknown |
| 2020-05-19 |
P020025-S126 |
Blazer II XP Cardiac Ablation Catheter and Cable |
Normal 180 Day Track No User Fee |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2020-05-15 |
P150031-S033 |
Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) Systems |
30-Day Notice |
NHL |
— |
— |
| 2020-05-15 |
P030017-S337 |
Precision Spinal Cord Stimulator (SCS) Systems |
30-Day Notice |
LGW |
— |
— |
| 2020-05-13 |
P180029-S023 |
LOTUS Edge Valve System |
30-Day Notice |
NPT |
— |
— |
| 2020-05-13 |
P150031-S032 |
Deep Brain Stimulation (DBS) Systems (Vercise, Vercise PC, and Vercise Gevia) |
30-Day Notice |
NHL |
— |
— |
| 2020-05-13 |
P030017-S336 |
Precision Spinal Cord Stimulator (SCS) Systems, (Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montag |
30-Day Notice |
LGW |
— |
— |
| 2020-05-06 |
P150003-S061 |
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2020-05-06 |
P110010-S178 |
Promus Premier, Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent System |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2020-05-05 |
P980037-S078 |
AngioJet Rheolythic Thrombectomy Catheter |
Normal 180 Day Track No User Fee |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2020-05-05 |
P140028-S055 |
Innova Vascular Self-Expanding Stent with Delivery System |
Normal 180 Day Track No User Fee |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2020-05-05 |
P110035-S056 |
Epic Vascular Self-Expanding Stent System |
Normal 180 Day Track No User Fee |
NIO |
Stent, Iliac |
Unknown |
| 2020-05-04 |
P150012-S094 |
INGEVITY lead family |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-04-24 |
P150031-S030 |
Vercise Deep Brain Stimulation (DBS) System, Vercise PC Deep Brain Stimulation (DBS) System, and Vercise Gevia Deep Brai |
30-Day Notice |
NHL |
— |
— |
| 2020-04-24 |
P030017-S335 |
Precision Spinal Cord Stimulator (SCS) System, Precision Spectra Spinal Cord Stimulator (SCS) System, Precision Novi⢠|
30-Day Notice |
LGW |
— |
— |
| 2020-04-22 |
P180011-S029 |
Eluvia Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2020-04-22 |
P140028-S058 |
Innova Self-Expanding Stent System |
30-Day Notice |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2020-04-20 |
P180011-S030 |
ELUVIA Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2020-04-20 |
P140028-S059 |
Innova Self-Expanding Stent System |
30-Day Notice |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2020-04-20 |
P110035-S059 |
Epic Vascular Self-Expanding Stent System |
30-Day Notice |
NIO |
Stent, Iliac |
Unknown |
| 2020-04-19 |
P180046-S004 |
Axonics Sacral Neuromodulation (SNM) System |
Real-Time Process |
EZW |
— |
— |
| 2020-04-17 |
P150005-S049 |
IntellaNav MiFi Open-Irrigated Ablation Catheter |
Normal 180 Day Track |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2020-04-17 |
P030017-S334 |
Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI, and Spectra WaveWriter Spinal Co |
30-Day Notice |
LGW |
— |
— |
| 2020-04-16 |
P180011-S025 |
Eluvia Drug-Eluting Vascular Stent System |
Real-Time Process |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2020-04-16 |
P150012-S093 |
INGEVITY MRI Lead and INGEVITY non-MRI Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-04-16 |
P140028-S053 |
Innova Vascular Self-Expanding Stent System |
Real-Time Process |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2020-04-15 |
P180046-S002 |
Axonics Sacral Neuromodulation (SNM) System |
Real-Time Process |
EZW |
— |
— |
| 2020-04-15 |
P180046-S001 |
Axonics Sacral Neuromodulation (SNM) System |
Real-Time Process |
EZW |
— |
— |
| 2020-04-13 |
P980037-S080 |
AngioJet Rheolythic Thrombectomy Catheter |
30-Day Notice |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2020-04-13 |
P190006-S004 |
Axonics Sacral Neuromodulation (SNM) System |
Real-Time Process |
QON |
— |
— |
| 2020-04-13 |
P140028-S057 |
Innova Vascular Self-Expanding Stent with Delivery System |
30-Day Notice |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2020-04-13 |
P110035-S058 |
Epic Vascular Self-Expanding Stent System |
30-Day Notice |
NIO |
Stent, Iliac |
Unknown |
| 2020-04-11 |
P130013-S037 |
WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2020-04-10 |
P190006-S010 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2020-04-10 |
P180046-S010 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2020-04-10 |
P150031-S026 |
Vercise PC and Vercise Gevia DBS Systems |
Real-Time Process |
NHL |
— |
— |
| 2020-04-09 |
P150003-S060 |
Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2020-04-09 |
N970012-S176 |
AMS 700 Series Product Line/Inflatable Penile Prosthesis with and without InhibiZone Treatment |
30-Day Notice |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2020-04-07 |
P960040-S451 |
ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, ICD AUTOGEN VR, ICD AUTOGEN |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-04-07 |
P190006-S009 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2020-04-07 |
P180046-S009 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2020-04-07 |
P110042-S136 |
S-ICD GEN 2 and S-ICD EMBLEM MRI |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-04-07 |
P010012-S519 |
ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, ICD AUTOGEN CRT-D, VIGILANT CR |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2020-04-03 |
P190006-S008 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2020-04-03 |
P190006-S007 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
QON |
— |
— |
| 2020-04-03 |
P180046-S008 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2020-04-03 |
P180046-S007 |
Axonics Sacral Neuromodulation System |
30-Day Notice |
EZW |
— |
— |
| 2020-04-03 |
P110010-S177 |
Promus PREMIER and Promus ELITE |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2020-04-02 |
P950020-S107 |
WOLVERINE Coronary Cutting Balloon |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2020-04-02 |
P130030-S068 |
REBEL Platinum Chromium Coronary Stent System |
30-Day Notice |
MAF |
Stent, Coronary |
Unknown |
| 2020-04-01 |
P960040-S446 |
ICD Devices: TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT and PERC |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-04-01 |
P910077-S176 |
LATITUDE NXT System - LATITUDE NXT Patient Management System, LATITUDE Wave Communicator and LATITUDE NXT System Server |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-04-01 |
P180011-S024 |
Eluvia Drug-Eluting Vascular Stent System |
Normal 180 Day Track No User Fee |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2020-04-01 |
P150012-S088 |
Pacemaker Devices - INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-04-01 |
P110042-S133 |
Subcutaneous ICD Devices: EMBLEM S-ICD |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-04-01 |
P010012-S514 |
CRT-D Resynchronization Devices: COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM |
Real-Time Process |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2020-04-01 |
N970003-S247 |
Pacemaker Devices - ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA and ALTRUA 2 supported |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-03-25 |
P950020-S105 |
WOLVERINE Coronary Cutting Balloon |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2020-03-20 |
P110042-S132 |
EMBLEM S-ICD System |
Normal 180 Day Track |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-03-17 |
P980033-S050 |
VENOUS WALLSTENT |
Panel Track |
QAN |
Stent, Iliac Vein |
Unknown |
| 2020-03-17 |
P960040-S449 |
ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI ICD DR |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-03-17 |
P950020-S097 |
WOLVERINE Coronary Cutting Balloon |
135 Review Track For 30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2020-03-17 |
P150031-S029 |
Vercise, Vercise PC, and Vercise Gevia Deep Brain Stimulation (DBS) Systems |
30-Day Notice |
NHL |
— |
— |
| 2020-03-17 |
P150012-S091 |
ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, and ACCOLADE MRI EL D |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-03-17 |
P110042-S135 |
SICD Gen 2 and SICD MRI |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-03-17 |
P030017-S333 |
Precision, Precision Novi, Precision Spectra, Spectra WaveWriter, Precision Montage, and Precision Montage MRI Spinal Co |
30-Day Notice |
LGW |
— |
— |
| 2020-03-17 |
P010012-S517 |
ORIGEN CRT-D, ORIGEN X4 CRT-D, MOMENTUM CRT-D, MOMENTUM, MOMENTUM X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, DYNAGEN CRT- |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2020-03-17 |
N970003-S250 |
ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR, ACCOLAD |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-03-11 |
P180029-S021 |
LOTUS Edge Valve System |
30-Day Notice |
NPT |
— |
— |
| 2020-03-06 |
P000053-S111 |
AMS 800 Series Product Line/Artifical Urinary Sphincter with and without InhibiZone Treatment |
30-Day Notice |
EZY |
Device, Incontinence, Mechanical/Hydraulic |
Gastroenterology, Urology |
| 2020-03-06 |
N970012-S175 |
AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment |
30-Day Notice |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2020-03-05 |
P960040-S448 |
ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, ICD AUTOGEN VR, ICD AUTOGEN |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-03-05 |
P950020-S104 |
Wolverine Coronary Cutting Balloon |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2020-03-05 |
P950020-S103 |
Wolverine Coronary Cutting Balloon |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2020-03-05 |
P150012-S090 |
PG ESSENTIO MRI SR, PG ESSENTIO MRI DR, PG PROPONENT MRI SR, PG PROPONENT MRI DR, PG ACCOLADE MRI SR, and PG ACCOLADE MR |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-03-05 |
P110042-S134 |
S-ICD GEN and S-ICD EMBLEM MRI |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-03-05 |
P010012-S516 |
ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, ICD AUTOGEN CRT-D, VIGILANT CR |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2020-03-05 |
N970003-S249 |
PG ADVANTIO DR, PG INGENIO DR, PG VITALIO DR, PG ESSENTIO SR, PG ESSENTIO DR, PG PROPONENT SR, PG PROPONENT DR, PG ACCOL |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-03-02 |
P130030-S066 |
REBEL Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) |
30-Day Notice |
MAF |
Stent, Coronary |
Unknown |
| 2020-03-02 |
P110010-S175 |
PROMUS Elite Everolimus-Eluting Platinum Chromium Coronary Stent System, PROMUS Premier Everolimus-Eluting Platinum Chro |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2020-03-02 |
P090003-S049 |
Express LD Premounted Iliac Stent System |
30-Day Notice |
NIO |
Stent, Iliac |
Unknown |
| 2020-03-02 |
P060006-S099 |
Express SD Premounted Renal Stent System |
30-Day Notice |
NIN |
Stent, Renal |
Unknown |
| 2020-02-28 |
P190006-S005 |
Axonics Sacral Neuromodulation (SNM) System |
30-Day Notice |
QON |
— |
— |
| 2020-02-28 |
P180046-S005 |
Axonics Sacral Neuromodulation (SNM) System |
30-Day Notice |
EZW |
— |
— |
| 2020-02-27 |
P180011-S027 |
Eluvia Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2020-02-27 |
P130013-S036 |
WATCHMAN Left Atrial Appendage Closure Device and Delivery System, WATCHMAN Access System |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2020-02-24 |
P950020-S102 |
WOLVERINE Coronary Cutting Balloon (Over-The-Wire and Monorail) |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2020-02-21 |
N970012-S174 |
AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without Inhibizone Treatment |
30-Day Notice |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2020-02-20 |
P950020-S101 |
WOLVERINE Coronary Cutting Balloon |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2020-02-20 |
P180011-S026 |
Eluvia Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2020-02-20 |
P140028-S054 |
Innova Vascular Self-Expanding Stent System |
30-Day Notice |
NIP |
Stent, Superficial Femoral Artery |
Unknown |
| 2020-02-20 |
P110035-S055 |
Epic Vascular Self-Expanding Stent System |
30-Day Notice |
NIO |
Stent, Iliac |
Unknown |
| 2020-02-19 |
P920047-S121 |
IntellaNav ST Temperature Ablation Catheter |
30-Day Notice |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2020-02-19 |
P150005-S052 |
Blazer OI, IntellaNav OI, IntellaTip MiFi OI, and IntellaNav MiFi OI Open-Irrigated Ablation Catheters |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2020-02-19 |
P020025-S125 |
IntellaTip MiFi XP, IntellaNav MiFi XP and IntellaNav XP Temperature Ablation Catheters |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2020-02-13 |
P140008-S016 |
ORBERA Intragastric Balloon System |
Normal 180 Day Track |
LTI |
Implant, Intragastric For Morbid Obesity |
Unknown |
| 2020-02-13 |
P000053-S104 |
AMS 800 Artificial Urinary Sphincter with InhibiZone |
Real-Time Process |
EZY |
Device, Incontinence, Mechanical/Hydraulic |
Gastroenterology, Urology |
| 2020-02-13 |
N970012-S163 |
AMS 700 Inflatable Penile Prosthesis |
Real-Time Process |
JCW |
Prosthesis, Penis, Inflatable |
Gastroenterology, Urology |
| 2020-02-12 |
P180011-S023 |
Eluvia Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2020-02-07 |
P920047-S120 |
Blazer Prime HTD |
30-Day Notice |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2020-02-07 |
P020025-S124 |
Blazer Prime XP and IntellaTip MiFi XP |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2020-02-06 |
P180011-S022 |
Eluvia Drug-Eluting Vascular Stent System |
30-Day Notice |
NIU |
Stent, Superficial Femoral Artery, Drug-Eluting |
Unknown |
| 2020-02-06 |
P110010-S174 |
Promus Element Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus Premier Everolimus-Eluting Platinum Ch |
30-Day Notice |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2020-01-30 |
P900056-S181 |
Rotapro Rotational Atherectomy System |
Normal 180 Day Track |
MCX |
Catheter, Coronary, Atherectomy |
Unknown |
| 2020-01-30 |
P180046-S003 |
Axonics Sacral Neuromodulation (SNM) System |
30-Day Notice |
EZW |
— |
— |
| 2020-01-28 |
P960040-S447 |
ICE ORIGEN VR DF4, VR DF1/IS1, DR DF4/IS1, DR DF1/IS1, ICD INOGEN VR DF4, VR DF1/IS1, DR DF4/IS1, DR DF1/IS1, ICD DYNAGE |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-01-28 |
P190006-S003 |
Axonics Sacral Neuromodulation (SNM) System |
30-Day Notice |
QON |
— |
— |
| 2020-01-28 |
P170023 |
Bulkamid Urethral Bulking System |
Original |
LNM |
Agent, Bulking, Injectable For Gastro-Urology Use |
Unknown |
| 2020-01-28 |
P150012-S089 |
PG ESSENTION MRI SR/DR SL, PG ESSENTIO DR EL, PG ESSENTIO MRI DR EL, PG PROPONENT MRI SR/DR/ SL, PG PROPONENT MRI DR EL, |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-01-28 |
P010012-S515 |
ICD ORIGEN CRT-D DF4/IS1, DF/IS1/ DF1/IS1/IS4, AND DF4/IS1/IS4, MMENTUM CRT-D IS1 DF4 IS1 |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2020-01-28 |
N970003-S248 |
PG ESSENTIO SR/DR SL, PG PROPONENT SR/DR SL, DR EL, PG ACCOLADE SR/DR SL, DR EL, PG ALTRUA 2 SR/DR SL, DR EL |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-01-27 |
P920047-S119 |
IntellaNav ST |
Real-Time Process |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2020-01-27 |
P150005-S051 |
IntellaNav OI and IntellaNav MiFi OI |
Real-Time Process |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2020-01-27 |
P020025-S123 |
IntellaNav MiFi XP amd IntellaNav XP |
Real-Time Process |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2020-01-24 |
P030017-S331 |
Percision, Precision Spectra, Spectra WaveWriter; Precision Novi, Percision Montage and Percision Montage MRI Spinal Co |
Real-Time Process |
LGW |
— |
— |
| 2020-01-14 |
P190006-S001 |
Axonics Sacral Neuromodulation (SNM) System |
Real-Time Process |
QON |
— |
— |
| 2020-01-09 |
P950020-S100 |
WOLVERINE Coronary Cutting Balloon Monorail |
30-Day Notice |
NWX |
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Unknown |
| 2020-01-09 |
P130030-S065 |
REBEL Platinum Chromium Coronary Stent System Monorail |
30-Day Notice |
MAF |
Stent, Coronary |
Unknown |
| 2020-01-03 |
P110010-S164 |
Promus Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System |
Normal 180 Day Track No User Fee |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |
| 2020-01-03 |
P110010-S163 |
PROMUS Element Plus, PREMIER and ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System |
Normal 180 Day Track No User Fee |
NIQ |
Coronary Drug-Eluting Stent |
Unknown |